MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 330 MM, DISSECTION FORCEPS, MARYLAND, SHORT; FORCEPS, LAPAROSCOPIC

Model Number	A64340A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the jaws, 5 x 330 mm, dissection forceps, is stuck in the set.The issue was found during preparation for use.Repair is not possible due to a damaged insert mechanism.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.A supplemental report will be submitted if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is to inform that upon further review, the initial medwatch was submitted in error.The event has already been reported on medwatch 9610773-2023-01493 (patient identifier (b)(6).Refer to this file for supplemental information related to this event.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, DISSECTION FORCEPS, MARYLAND, SHORT
• Common Device Name: FORCEPS, LAPAROSCOPIC
• 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: 17413954
• Report Number: 9610773-2023-02046
• Device Sequence Number: 12546458
• Product Code: HET
• UDI-Device Identifier: 04042761010269
• UDI-Public: 04042761010269
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: A64340A
• Device Lot Number: 22801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2022
• 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