MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP

Model Number	WA22507D
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that during an endometrial hysterectomy, the surgeon found the loop wire of the high frequency resection electrode was cut in two.The device was replaced, and the procedure was completed.Although there was a delay of intervention and increase of anesthesia time for the obese patient, no patient injury was confirmed.
Additional Manufacturer Narrative
A review of the manufacturing and quality records for the affected lot number was reviewed without detecting any non-conformities or deviations regarding the described issue.The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.Additional 510(k): k100275.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer and to provide additional information based on the legal manufacturer's final investigation.Updated fields: b1, b2, b5, d8, e1, h1, h3 and h6.A manufacturing and quality control review was performed for the affected lot number/serial number without showing any non-conformities or deviations regarding the described issues.The result of our investigation is consistent with the customer's description of failure.The customer reports that the electrode is ¿cut in two¿.During investigation, olympus identifies that the loop of the electrode is broken and the ends of the wire are melt down.Additionally, the fork of the electrode is deformed.Based on the burn marks and signs of thermal stress, olympus assumes that the electrode loop has been clearly deformed during the reported incident.No error message of the generator is reported.The cause is very likely improper handling/excessive force by the user.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Olympus further received information that the piece of the device was recovered from the patient's body.The operating mode was bipolar in saline.There was a fifteen-minute procedure delay.No other information provided.

• Brand Name: HF-RESECTION ELECTRODE, LOOP
• Common Device Name: ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 17046789
• Report Number: 9610773-2023-01508
• Device Sequence Number: 18327716
• Product Code: FAS
• UDI-Device Identifier: 14042761068236
• UDI-Public: 14042761068236
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA22507D
• Device Catalogue Number: WA22507D
• Device Lot Number: 1000105911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• 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: 05/03/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female