MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., LARGE, 30°, WITH CABLE, STERILE,; RESECTION SHEATH, 24 FR.

Model Number	WA22607D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned to olympus for evaluation.The cause of the user's experience cannot be determined.If additional and significant information becomes available at a later time, this report will be supplemented.
Event or Problem Description
Olympus received a medwatch (report# (b)(4)), which stated that while the doctor was performing a turp and using the button turp loop, the loop broke while cauterizing the prostate.The ends of the loop curled up.The entire loop is still there, it just curled up at the ends.A new loop was obtained and the procedure continued with no harm to the patient.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct the medwatch report number in section b5 and update section g3 with the medwatch report number.
Event or Problem Description
Olympus received medwatch report #3302260000-2019-8007.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., LARGE, 30°, WITH CABLE, STERILE,
• Common Device Name: RESECTION SHEATH, 24 FR.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 8405938
• Report Number: 2951238-2019-00526
• Device Sequence Number: 16657623
• Product Code: FAS
• UDI-Device Identifier: 14042761075487
• UDI-Public: 14042761075487
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K102781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: WA22607D
• Device Catalogue Number: WA22607D
• Device Lot Number: 806847
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 02/09/2020
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 102