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

Model Number	WA64130A
Medical Device Problem Codes	Material Deformation (2976); Unclear Information (4052)
Health Effect - Clinical Codes	Bowel Perforation (2668); Insufficient Information (4580)
Date of Event	10/28/2021
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 an unspecified therapeutic procedure harm was caused to a patient with a grasper.The affected model number is not confirmed at the current state and is used to process this case.No further information was provided.
Event or Problem Description
Olympus was informed that during a therapeutic laparoscopic hernia repair procedure, the patient sustained an injury to the bowel and required a bowel resection.No further information was provided.
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.
Additional Manufacturer Narrative
Additional information: h6 - adverse event problem - medical device problem code device evaluation: the suspect medical device as well as the concomitant devices were returned to the manufacturer for evaluation/investigation.The evaluation/investigation found the jaws insert to be bent laterally at mid-length.The shaft was found heavily deformed at its distal end.This most likely happened due to excessive force being exerted during disassembly.The handle provided for investigation was evaluated as meeting its specification.The event/incident was attributed to use error.A manufacturing and quality control review was performed for the affected lot numbers of the jaws insert and the concomitant devices 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(HANDLES, SHAFTS, JAWS INSERTS)
• 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: 12769657
• Report Number: 9610773-2021-00317
• Device Sequence Number: 3310428
• Product Code: GCJ
• UDI-Device Identifier: 04042761010160
• UDI-Public: 04042761010160
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: WA64130A
• Device Catalogue Number: WA64130A
• Device Lot Number: 19704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• 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: 10/29/2021
• Supplement Date Received by Manufacturer: 11/29/2021; 02/24/2022
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 12/21/2021; 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2019
• 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, RATCHET (A60100A); OLYMPUS SHAFT "HIQ+", 5 X 330 MM (A60800A)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown