MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE MECHANICAL LITHOTRIPTOR V

Model Number BML-V442QR-30

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the returned device is still ongoing.The cause of the reported event cannot be conclusively determined at this time.If additional and significant information is received this report will be supplemented.

Event Description

Olympus was informed that during the procedure the end piece (tip) broke off.No patient injury occurred.

Manufacturer Narrative

This supplemental report is being submitted to provide the physical evaluation of the device and to update the following sections.A visual inspection was performed and found the distal rubber tip (where the guidewire is inserted) was missing and not returned.The missing piece is about 7 mm in length.The distal end of the device was closely examined and found minor scratch marks and a small portion of the rubber tip adhered inside the distal end.The v marking was bent and stressed.Also, there is a sticky foreign substance adhered to the pipe causing resistance while operating the pipe.The basket was found still intact as the basket could be opened, closed, and functioned without issue.Based on the investigation findings and similar reported events, the most probable cause of the reported event could be attributed to (unintended) operational error.The instruction manual provides warning which states, ¿when using the guide wire, insert the instrument with its distal tip in parallel with the guide wire.Careful not to forcibly insert the instrument with a sharp angle between the distal tip and the guide wire as this may damage the distal tip.Also, do not crush the calculus while the guidewire remains in the distal tip.This may also damage the instrument.¿.

• Brand Name: SINGLE USE MECHANICAL LITHOTRIPTOR V
• Type of Device: SINGLE USE MECHANICAL LITHOTRIPTOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8144690
• MDR Text Key: 130661575
• Report Number: 2951238-2018-00752
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 04953170218422
• UDI-Public: 04953170218422
• Combination Product (y/n): N
• PMA/PMN Number: K903529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BML-V442QR-30
• Device Lot Number: 74K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1