MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", BIPOLAR, 5 X 330 MM, PREPARATION FORCEPS, MARYLAND, SHORT; HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR

Model Number	WA64320C
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
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 laparoscopic cholecystectomy the forceps sparked and could no longer be opened or closed.The forceps where then removed and it was found that the insulation at the distal end of the jaws insert was broken off.It is unclear whether the broken fragment remained inside the patient.The intended procedure was completed using the same set of equipment and so far there has been no report about an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus medical systems corporation (omsc), japan (returned to omsc on 2021-10-12).The evaluation at omsc confirmed that parts of the insulation at the distal end of the jaws insert are missing and the remaining insulation is worn.Furthermore, the entire jaw area is heavily contaminated.The ceramic axis connection between the jaw parts is damaged/cracked presumably as a result of at least one hf current flashover.The entire instrument shows signs of acute use-related wear and inadequate reprocessing.Therefore, the reported event/incident was attributed to use error.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the jaws insert 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.

• Brand Name: JAWS "HIQ+", BIPOLAR, 5 X 330 MM, PREPARATION FORCEPS, MARYLAND, SHORT
• Common Device Name: HAND INSTRUMENTS, STANDARD, BIPOLAR AND MONOPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 12546229
• Report Number: 9610773-2021-00273
• Device Sequence Number: 4986276
• Product Code: GEI
• UDI-Device Identifier: 04042761062442
• UDI-Public: 04042761062442
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984417
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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
• Operator of Device: Health Professional
• Device Model Number: WA64320C
• Device Catalogue Number: WA64320C
• Device Lot Number: 12ZW-0009
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS HANDLE "HIQ+", ERGO, BIPOLAR; OLYMPUS SHAFT "HIQ+", BIPOLAR, 5 X 330 MM; OLYMPUS HANDLE "HIQ+", ERGO, BIPOLAR; OLYMPUS SHAFT "HIQ+", BIPOLAR, 5 X 330 MM
• Patient Sex: Unknown