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 Code	Activation Failure (3270)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/26/2022
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 patient's outcome 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 myoma enucleation procedure the jaws insert did not work in bipolar mode when combined with the erbe vio3 electrosurgical unit.After exchange of the vio3 electrosurgical unit with an erbe vio 200d device, the procedure could be completed but the patient suffered increased blood loss and the surgery time was prolonged.
Additional Manufacturer Narrative
The suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation found distinct signs of wear and tear on the device as well as traces of a third-party repair attempt.However, no malfunction of the device was determined and it was found to be working correctly.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.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.However, the reported phenomenon 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 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 14369374
• Report Number: 9610773-2022-00168
• Device Sequence Number: 2006647
• Product Code: GEI
• UDI-Device Identifier: 04042761062442
• UDI-Public: 04042761062442
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: WA64320C
• Device Catalogue Number: WA64320C
• Device Lot Number: 115W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2011
• 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: ERBE VIO 200D ELECTROSURGICAL UNIT.; ERBE VIO3 ELECTROSURGICAL UNIT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female