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

Model Number A22205C

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, olympus followed-up with the user facility to obtain additional information.On april 25, 2019, the user facility further reported that the loop at the distal end of the device broke off and fell into the patient¿s prostatic urethra.The loop was retrieved and the device was removed from the patient without harm.In addition, the procedure was prolonged by 5 minutes.There was no sparking/arcing observed during procedure.There was no unexpected bleeding to the patient observed and the patient did not require a longer stay or additional treatment.Prior to procedure, the electrode was inspected with no irregularities noted.The generator settings were set to 200 cut, 80 coag; no error message was displayed.The oem conducted a review of the device history records (dhr) for the referenced device/lot number and there was no deviations or non-conformities noted during the manufacturing process.The referenced device will not be returned to olympus, therefore, the exact cause of the reported event cannot be confirmed.However, based on similar reported complaints, the reported event can potentially occur if the electrode comes into contact (unintended) with other metal parts, e.G.Surgical instruments while the high-frequency output was activated.As a preventive measure, the instruction manual contains several warning and caution statements in an effort to prevent damage to the electrode.Visually inspect the instrument prior to use.Warped electrodes, defective insulation and broken, cracked, or irregular cutting loops represent a danger for both the patient and the surgeon and must not be used.If the instrument is damaged or does not function properly, replace it.

Event Description

Olympus was informed that during a transurethral resection of a prostate (turp) procedure, the loop at the distal end of the device appeared to be thinning out and the loop would break at the apex.The intended procedure was completed utilizing a second like device from the same lot.The reported event did not impact the outcome of the procedure.There was no patient injury reported.The reported device was discarded by the user facility following the procedure.

Manufacturer Narrative

This supplemental report is being submitted in order to provide additional information related to the event.

Event Description

Additional information was reported that the loop did not fall into the patient.The loop failed.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR
• Type of Device: HF ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 8556616
• MDR Text Key: 143455425
• Report Number: 2951238-2019-00775
• 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
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

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
• Device Operator: No Information
• Device Model Number: A22205C
• Device Catalogue Number: A22205C
• Device Lot Number: 1000032107
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1