MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE; HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)

Model Number	A4829
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient¿s outcome and the reported phenomenon could not be determined and is being judged as unknown.However, based on the information provided it is assumed that the reported damage was caused by excessive force applied by the user while rotating the grasping forceps during use.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 case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.
Event or Problem Description
Olympus was informed that during a therapeutic transurethral resection of a bladder tumor (turbt) procedure, one side at the distal end of the grasping forceps broke during the procedure and fragments fell into the patient.However, no fragments remained inside the patient since they were reportedly retrieved.The intended procedure was completed using another similar device and there was no report about a patient injury.

• Brand Name: GRASPING FORCEPS, SHARK TEETH, 7 FR., SEMIFLEXIBLE
• Common Device Name: HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): DAUSCH MEDIZINTECHNIK GMBH; daimlerstrasse 13; wurmlingen 78573 ; GM 78573
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 16092979
• Report Number: 9610773-2023-00064
• Device Sequence Number: 12423299
• Product Code: GEI
• UDI-Device Identifier: 04042761006927
• UDI-Public: 04042761006927
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: 510(K)EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: A4829
• Device Catalogue Number: A4829
• Device Lot Number: 225W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown