MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35; HF ELECTRODE, LOOP

Model Number	A22205C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The exact cause of the reported event could not be confirmed, however, based on similar reported complaints the reported event can occur from mechanical overload by the application of excessive force and or the electrode comes into contact (unintended) with other metal parts, e.G.Surgical instruments while the high-frequency output was activated.If the device is returned at a later date, this report will be supplemented accordingly.
Event or Problem Description
Olympus was informed that during a transurethral resection of a prostate (turp) procedure, the loop wire at the distal end of the device broke off and fell into the patient¿s bladder.The device was retrieved from the patient.There was no delay in the procedure as the intended procedure was completed using a second device from the same lot.In addition, there was no sparking or arcing observed during procedure; there was no unexpected bleeding to the patient; there was no issue withdrawing the device from the patient and the patient did not require additional procedures or treatment.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation results.A visual inspection was performed on the received condition and confirmed the loop wire at the distal end of the device was broken and missing.A microscope inspection revealed char marks and melting at the breakage point on both yellow colored insulation posts at the distal tip.The two insulation posts at the distal section were bent inward; the red insulation shaft is straight, and its proximal end has no physical damage.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35
• Common Device Name: HF ELECTRODE, LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• MDR Report Key: 8192363
• Report Number: 2951238-2018-00801
• Device Sequence Number: 11205203
• Product Code: GCP
• UDI-Device Identifier: 14042761036709
• UDI-Public: 14042761036709
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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: No Information
• Device Model Number: A22205C
• Device Lot Number: 1000024185
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1