Single Use Mechanical Lithotriptor V
Brand(s)
Last updated
Summary
Product
Single Use Mechanical Lithotriptor V
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Single Use Mechanical Lithotriptor V | 3ZK 3XK 3YK 33K-39K 41K-44K | BML-V442QR-30 |
Issue
Olympus has identified an increase in complaints for BML-V442QR-30. The complaint data analysis found that distal tip tearing of the Mechanical Lithotriptor V had increased beginning with the production of lot 33k. Olympus has identified 296 complaints for the BML-V442QR-30 globally between June 1, 2021, through July 31, 2024. There were 169 reportable malfunctions, and there was one report of a serious injury in relation to this issue.
Recall start date: December 18, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
| Olympus Medical Systems Corp. |
| 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76779
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