MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12 AND 30 TELESCOPE; OPTICAL FORCEPS

Model Number	A20710A
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Remove (1528); Mechanical Jam (2983); Device Handling Problem (3265)
Health Effect - Clinical Codes	Incontinence (1928); Injury (2348)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during a therapeutic transurethral bladder stone removal procedure and lithotripsy, the jaws of the suspect medical device could not be closed anymore while attempting to crush, grasp and retrieve the crushed bladder stones.The grasping forceps then had to be removed in open position causing injury to the patient's urethra.As a result, the patient currently suffers from (temporary) incontinence.The intended procedure was reportedly completed.
Additional Manufacturer Narrative
Device evaluation: the suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed the reported phenomenon of a damaged grasping forceps.Causal for this damage is mechanical overload which led to the overload protection being engaged.In addition, the jaws were found jammed in open position and cannot be closed anymore by operating the handle.This defect is considered to be a design flaw and a capa and subsequent change have been initiated to adapt the design of the grasping forceps and prevent the jamming of the jaws in case the overload protection is engaged.Thus, this event/incident was attributed to use error in combination with a design weakness.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the grasping forceps without showing any abnormalities.The reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12 AND 30 TELESCOPE
• Common Device Name: OPTICAL FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7808827
• Report Number: 9610773-2018-00078
• Device Sequence Number: 1469075
• Product Code: GCP
• UDI-Device Identifier: 04042761019989
• UDI-Public: 04042761019989
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: A20710A
• Device Catalogue Number: A20710A
• Device Lot Number: 178W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention