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

Model Number WA22302D

Device Problems Break (1069); Electrical Shorting (2926)

Patient Problem Blood Loss (2597)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

The electrode was not returned to olympus for evaluation and is currently being retained by the user facility while an internal investigation is being conducted.Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result.The cause of the reported event cannot be determined at this time.As part of our investigation, the original equipment manufacturer (oem) performed a manufacturing and quality control review for the affected lot number without showing any non-conformities or deviations regarding the related issue.If additional information becomes available or if the device is received at a later date, this report will be supplemented accordingly.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the electrode became really hot and shorted out.At that time two pieces of the electrode broke off and fell into the patient¿s prostate causing 300ml of blood loss.It is unknown if the intended procedure was completed.The patient¿s course of treatment is unknown.

Manufacturer Narrative

The device was returned to the service center for evaluation.A visual inspection was performed on the received device and noted the loop at the tip of the hf electrode was broken.The loop of the resection electrode was more than 50 percent broken from the distal end side.No functionally test could be performed due to the electrode being broken.The distal end was further inspected and noted that one of the legs near the distal end was bent upward.The shaft was checked and noted to be bent in the middle section.Additionally, there is evidence of foreign material around the remaining loop section.The broken portion of the loop wire was not returned with the device for evaluation.Based on the evaluation, the exact cause of loop breakage could not be determined.The most likely cause for the electrode loop breakage is the loop coming into contact with a metal instrument when energy was activated.The bent distal end is attributed to mishandling.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR.,
• Type of Device: HF-RESECTION ELECTRODE, LOOP, 24 FR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 8542524
• MDR Text Key: 143038490
• Report Number: 2951238-2019-00760
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• Combination Product (y/n): N
• PMA/PMN Number: K100275
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22302D
• Device Catalogue Number: WA22302D
• Device Lot Number: 1000031165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other