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

Model Number A20710A

Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Mechanical Jam (2983); Device Handling Problem (3265)

Patient Problems Incontinence (1928); Injury (2348)

Event Date 08/17/2018

Event Type  Injury  

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 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.

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
• Type of Device: OPTICAL FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• MDR Report Key: 7808827
• MDR Text Key: 117988859
• Report Number: 9610773-2018-00078
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 04042761019989
• UDI-Public: 04042761019989
• Combination Product (y/n): N
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention