MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, MARYLAND, BIPOLAR; CUTTING DEVICE

Model Number	WA69416M
Medical Device Problem Codes	Mechanical Problem (1384); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed.The white component/part above the jaws appears to be broken or torn and the jaws could not close completely.There were no additional findings.The investigation is ongoing, and 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 to olympus that the jaws insert "hicura", 5 x 330, maryland, bipolar inner part to maryland bipolar forceps was bent.The event was found during reprocessing for a laparoscopic hysterectomy.There was no delay, and the procedure was completed with the same device.There was no patient harm associated with the event.The device was evaluated, and it was found that the white component/part above the jaws appeared to be broken or torn and the jaws would not close completely.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
Corrected fields: e1 (information was inadvertently missed).The customer reported issue, inner part of the jaws is bent, was not confirmed.The proximal end of the transmission rod is deformed and the insulation is worn.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 deformation occurred due to the use of excessive force by the user and defective insulation due to wear and tear.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, MARYLAND, BIPOLAR
• Common Device Name: CUTTING DEVICE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, lund 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: 17681839
• Report Number: 9610773-2023-02448
• Device Sequence Number: 6246320
• Product Code: GEI
• UDI-Device Identifier: 04042761080002
• UDI-Public: 04042761080002
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: WA69416M
• Device Lot Number: 20802-0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2020
• 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