MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, 5 FR., SEMI-FLEXIBLE, STANDARD; HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)

Model Number A2500

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2016

Event Type  malfunction  

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 lithotripsy (tul) procedure, the axel pin at the distal end of the grasping forceps detached and fell inside the patient's kidney.The intended procedure was successfully completed with another similar device and there was no report of an adverse event or patient injury.An x-ray confirmed that the fragment was inside the renal pelvis of the patient's kidney.However, rather than intervene, it was decided to watch and wait for the fixing pin to be excreted naturally.

Manufacturer Narrative

Device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the manufacturer's evaluation/investigation was exclusively performed on the basis of the provided information.According to the available photo documentation, the axel pin at the distal end of the grasping forceps is detached and the bracket housing the jaw joint is severely deformed.The cause of this damage is mechanical overload by the application of excessive force.Therefore, this event/incident was attributed to abnormal use/off-label use.Furthermore, 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 related to function and safety.The case will be closed from olympus side with no further actions.However, the event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results and retrained to correctly use the olympus medical devices.

• Brand Name: GRASPING FORCEPS, 5 FR., SEMI-FLEXIBLE, STANDARD
• Type of Device: HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 22045 ; GM 22045
• Manufacturer (Section G): BACHER JOSEF GMBH; eisenbahnstrasse 19; rietheim-weilheim, 78604 ; GM 78604
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 40 66966
• MDR Report Key: 6176522
• MDR Text Key: 62866253
• Report Number: 9610773-2016-00053
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2500
• Device Catalogue Number: A2500
• Device Lot Number: 155W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1