MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 330 MM, NEEDLE HOLDER, STRAIGHT; NEEDLE HOLDER, REUSABLE

Model Number	WA64700A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus employee reported on behalf of a customer, during a surgery, the grasping part at the tip of needle holder insert was bent to the right.The issue would not allow for the subject device to perform in the manner they were aiming for.The unspecified therapeutic procedure was completed without having to change the subject device.There was no report of patient harm associated with this event.
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is to inform that upon further review, this is not a reportable malfunction.The initial medwatch reported the grasping part at the tip of needle holder insert was bent to the right; however; per the legal manufacturer, this issue is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, NEEDLE HOLDER, STRAIGHT
• Common Device Name: NEEDLE HOLDER, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18297809
• Report Number: 9610773-2023-03571
• Device Sequence Number: 7438714
• Product Code: GCJ
• UDI-Device Identifier: 04042761031097
• UDI-Public: 04042761031097
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: WA64700A
• Device Lot Number: 23303-021
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 03/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SET HANDLE
• Patient Sex: Unknown