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

Model Number	WA64130A
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	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus was informed that during a therapeutic laparoscopic liver resection procedure one jaw at the distal end of the jaws insert broke off and fell into the patient.However, no fragment remained inside the patient since it was reportedly retrieved.The intended procedure was completed using another similar device and there was no report about an adverse event or patient injury.
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.
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus medical system corporation (omsc), japan (returned to omsc on 2022/06/13).The evaluation at omsc confirmed that one jaw at the distal end of the jaw insert is broken off.In addition, the device shows scratches, cracks and traces of rust.This damage is caused by wear and tear in combination with rough handling.Therefore, this 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 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+", 5 X 330 MM, JOHANN LONG
• 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: 14617915
• Report Number: 9610773-2022-00208
• Device Sequence Number: 4509265
• Product Code: GCJ
• UDI-Device Identifier: 04042761030717
• UDI-Public: 04042761030717
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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: WA64130A
• Device Catalogue Number: WA64130A
• Device Lot Number: 18902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2018
• 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 SHAFT "HIQ+", 5 X 330 MM (A60800A).
• Patient Sex: Unknown