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

Model Number WA22507D

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2023

Event Type  Injury  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 317635659
• Report Number: 9610773-2023-01508
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761068236
• UDI-Public: 14042761068236
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female