MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE; HF-RESECTION ELECTRODES

Catalog Number WA22301D

Device Problem Melted (1385)

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

Event Date 11/10/2014

Event Type  malfunction  

Event Description

Olympus was informed that during an unspecified therapeutic transurethral resection (tur) procedure, the surgical team noticed that the loop wire of the hf resection electrode was broken/melted and missing after the operating surgeon removed the suspect medical device from and reinserted it into the patient.It is unknown when exactly this damage occurred and whether a fragment/part fell inside the patient during the procedure which was reportedly completed by using another hf resection electrode.However, no pieces were found during search and x-ray was taken postoperatively where no foreign objects were noted.There was also no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was not yet returned to the manufacturer for evaluation/investigation.Therefore the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.Olympus submits this incident as a medical device report (mdr) in abundance of caution.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE
• Type of Device: HF-RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 2204 5; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 0669662955
• MDR Report Key: 4309454
• MDR Text Key: 5269468
• Report Number: 9610773-2014-00052
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/10/2014

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: Health Professional
• Device Catalogue Number: WA22301D
• Device Lot Number: 14140P01L001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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
• Treatment: OLYMPUS UES-40S ELECTROSURGICAL GENERATOR