MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24-28 FR., 45 AN; HF-RESECTION ELECTRODES

Catalog Number WA22558C

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

Olympus was informed that during a therapeutic transurethral enucleation of the prostate with bipolar (tueb) procedure, the loop wire of the hf resection electrode broke off and fell inside the patient.However, no fragments/parts remained inside the patient as they were reportedly retrieved by unspecified instrument.Furthermore, the intended procedure was completed by using another similar device and there was no report about an adverse event or patient injury.

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation as it was reportedly discarded by the user facility.Furthermore, a manufacturing and quality control review could not be performed as basic data of article identification (lot number) are missing.Therefore the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.The case will be closed from olympus side with no further actions.However, the incident/phenomenon will be recorded for trending and surveillance purposes and if 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, 24-28 FR., 45 AN
• 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: 4377432
• MDR Text Key: 5262179
• Report Number: 9610773-2014-00055
• 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: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/12/2014

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: WA22558C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 12/22/2014
• 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
• Treatment: OLYMPUS ESG-400 ELECTROSURGICAL GENERATOR; (SERIAL # (B)(4))
• Patient Outcome(s): Other