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

Model Number A22205C

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2018

Event Type  malfunction  

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 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.

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
• Type of Device: HF ELECTRODE, LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• MDR Report Key: 8192363
• MDR Text Key: 131772804
• Report Number: 2951238-2018-00801
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036709
• UDI-Public: 14042761036709
• Combination Product (y/n): N
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A22205C
• Device Lot Number: 1000024185
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1