MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ANGLED LOOP, 24 FR., 12°, LONG, STERILE, SINGLE USE; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number	WA22039C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant devices: "thunderbeat generator" per customer-could be esg-400 or usg-400, exact model/serial numbers could not be provided by the customer.The device referenced in this report cannot be returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported by the customer (and in mw5103123), during a transurethral resection of the prostate (turp) using a single use hf-resection electrode, the electrode broke inside the patient's urethra.Most of the device fragments were removed using other unspecified instruments.Post-operative x-rays did not demonstrate any retained foreign body.The customer could not confirm if there were any procedural complication or anatomical challenges that could have caused or contributed to the reported event.There were no adverse effects to the patient as a result of this occurrence.The patient's current condition is reported as: patient was discharged from this hospital admission.The settings used for the procedure were 120/200 cut.The customer was unable to provide any further information regarding the patient, devices used, or event.
Additional Manufacturer Narrative
This report is being submitted to report investigation findings.New information is reported in d8, h4, h6, and h10.Device history review (dhr) a manufacturing and quality control review was performed for device model wa22039c with the reported lot number.There is no non-conformity associated with this device with respect to the described issue.The instructions for use (ifu) shipped with the device instructs the user that a suitable replacement device must be available during a procedure, and that the function of all devices must be checked prior to every procedure.It is important to note that the "thunderbeat generator" (usg-400) mentioned by the customer does not have a monopolar output socket.It is therefore assumed that this is a reporting error and that an esg-400 generator was used.Cause: based on the available information and the investigation findings, the cause of the reported issue is most likely attributed to the use of excessive force as well as wrong handling.

• Brand Name: HF-RESECTION ELECTRODE, ANGLED LOOP, 24 FR., 12°, LONG, STERILE, SINGLE USE
• Common Device Name: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• 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: 12624268
• Report Number: 9610773-2021-00291
• Device Sequence Number: 11790239
• Product Code: GCP
• UDI-Device Identifier: 14042761051603
• UDI-Public: 14042761051603
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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 Model Number: WA22039C
• Device Catalogue Number: WA22039C
• Device Lot Number: 1000043436
• Was Device Available for Evaluation?: No
• 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: 09/27/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2019
• 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: Male