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

Model Number	A64810A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to a 3rd party repair center for evaluation and the reported issue was confirmed.The device evaluation found that the distal end of the jaw was broken.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported that the insert scissors mechanism is damaged.The issue was found in preparation for use in an unspecified procedure.There were no reports of harm.
Additional Manufacturer Narrative
Corrected fields: e1 (inadvertently missed), g2 (added selection), d9 this report is being supplemented to provide additional information based on the legal manufacturer's final investigation and additional information received from the customer.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 wear and tear.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information was provided.The intended procedure was for a therapeutic laparoscopic cholecystectomy.The procedure was completed without delay using another similar device.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, SCISSORS, METZENBAUM
• Common Device Name: JAWS
• 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: 17560445
• Report Number: 9610773-2023-02265
• Device Sequence Number: 3584174
• Product Code: HET
• UDI-Device Identifier: 04042761010320
• UDI-Public: 04042761010320
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K944200
• 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,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,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: 178W-0045
• 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: 08/30/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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