MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE FOR TCRIS; ELECTRODE "PLASMA LOOP

Model Number	WA47506S
Medical Device Problem Codes	Melted (1385); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, "surgeon was using a resectoscope with a loop electrode in the uterus.At the end of the case (unspecified procedure) the loop was removed from the uterus and it was noted that the loop electrode was split and visually it appeared that the loop had melted on one side of the electrode".There was no patient harm , no adverse event reported due to the event.No user injury reported.
Additional Manufacturer Narrative
The subject device was received at service business center for evaluation, however, the evaluation is still pending.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information obtained from the customer.Please see update to b5.
Event or Problem Description
Additional information was received from the customer which noted the reported event (loop appeared to be melted on the side of electrode) occurred during a therapeutic procedure.The procedure was completed when the breakage and the reported event was noted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, as well as corrections to d9 and g2.D9: the device was not returned for evaluation, as the customer confirmed that the device was misplaced.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, it¿s likely the reported event (loop appeared to be melted on the side of electrode) was due to wear and tear.The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE FOR TCRIS
• Common Device Name: ELECTRODE "PLASMA LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61,; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15587706
• Report Number: 9610773-2022-00472
• Device Sequence Number: 2810232
• Product Code: JOS
• UDI-Device Identifier: 14042761085042
• UDI-Public: 14042761085042
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161600
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2022

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: WA47506S
• Device Catalogue Number: WA47506S
• Device Lot Number: 1000080709
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/10/2022
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 10/14/2022; 11/15/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/10/2022; 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2021
• 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
• Patient Sex: Unknown