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

Model Number A22205C

Device Problem Break (1069)

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

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.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE
• Type of Device: HF ELECTRODE, LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8192390
• MDR Text Key: 132061062
• Report Number: 2951238-2018-00802
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036709
• UDI-Public: 14042761036709
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2018

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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1