MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 430 MM, SCISSORS, METZENBAUM; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	A64810L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus.The issue reported by the customer is evaluated as plausible.According to the event description, the distal end of the item is broken.The item does not comply with the product specification and can no longer be used.Based on the results of the investigation, the cause is very likely excessive force, exerted during a third-party repair.Despite best efforts, the lot/serial number for the affected device could not be obtained.Therefore, a dhr review could not be performed.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported, the plier insert broken on distal end.The issue occurred during preparation for use.There were no reports of patient harm.

• Brand Name: JAWS "HIQ+", 5 X 430 MM, SCISSORS, METZENBAUM
• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18847800
• Report Number: 9610773-2024-00631
• Device Sequence Number: 15412043
• Product Code: HET
• UDI-Device Identifier: 04042761010337
• UDI-Public: 04042761010337
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2024

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: A64810L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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