MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12/16, ESG TURIS

Model Number	WA22703S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.The loops were not returned to the service center for evaluation.The original equipment manufacturer (oem) performed a dhr review.The manufacturing and quality control review was performed for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.The exact cause of the reported event could not be determined at this time.An investigation is ongoing to obtain additional information regarding the reported event.Please reference related patient id: (b)(6).
Event or Problem Description
The customer reported that during a therapeutic transurethral resection of the prostate (turp) the loops from two hf-electrodes broke off inside the patient.It was reported that loops were retrieved with an unknown device.The intended procedure was completed with a third loop without further issue.There was no patient injury reported.In addition, on july 09, 2021, olympus received a voluntary medwatch (mw5101862) pertaining to the events stated in this report and no additional information provided.This mfr.Report addresses loops 1 of 2.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer (lm) investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer provided the following possible cause for the reported event were as follows: the legal manufacturer reported that according to the investigators, the cause of the reported issue is most likely due to wear and tear.Please note that the loop at the distal end of the electrode wears out during use and may break, burn or melt.This product was sold on july 01, 2021.The legal manufacturer provided the following risk statement ¿the risk to patients, users, and/or third parties associated with the reported issues is acceptable.¿ there are no countermeasures necessary because the associated risk is acceptable.Oste will monitor the occurrence rate in the context of our quality management system.If necessary, oste will take action in the future.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12/16, ESG TURIS
• Common Device Name: HF-RESECTION ELECTRODE "PLASMALOOP"
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 12232054
• Report Number: 9610773-2021-00209
• Device Sequence Number: 3620917
• Product Code: FAS
• UDI-Device Identifier: 14042761085332
• UDI-Public: 14042761085332
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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 Expiration Date: 10/08/2025
• Device Model Number: WA22703S
• Device Catalogue Number: WA22703S
• Device Lot Number: 1000065159
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WA22702S "PLASMALOOP", LOOP, MEDIUM, 24 FR.,
• Patient Age: 74 YR