MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 330 MM, SCISSORS, METZENBAUM; FORCEPS

Model Number	A64810A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the insert scissors mechanism is damaged on the jaws, 5 x 330 mm, scissors, metzenbaum.The issue was found during preparation for use for an unknown procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation and follow up with the user facility is currently being performed.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.
Event or Problem Description
The intended procedure was laparoscopic cholecystectomy.The intended procedure was completed with a similar device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Updated fields: b3; b5.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned to olympus, but was inspected by a third party.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause could not be conclusively determined.It is likely the reported event occurred due to the use of excessive force by the user.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The intended procedure was therapeutic.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, SCISSORS, METZENBAUM
• Common Device Name: FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17537841
• Report Number: 9610773-2023-02210
• Device Sequence Number: 6496128
• Product Code: HET
• UDI-Device Identifier: 04042761010320
• UDI-Public: 04042761010320
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K944201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2023

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: A64810A
• Device Lot Number: 19605-039
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 08/28/2023; 08/31/2023
• Initial Report FDA Received Date: 08/12/2023
• Supplement Report FDA Received Date: 08/28/2023; 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2019
• 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
• Patient Sex: Unknown