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

Catalog Number A22205D

Device Problem Break (1069)

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

Event Date 01/22/2015

Event Type  malfunction  

Event Description

Olympus was informed that during an unspecified therapeutic transurethral resection (tur) procedure, the loop wire of the suspect medical device broke inside the pt.However, no fragments/parts fell off.The intended procedure was subsequently completed by using another similar device.No other info was provided but there was no report about an adverse event or pt injury.

Manufacturer Narrative

The suspect medical device was not returned to the mfr for eval/investigation but to olympus medical systems corporation (omsc), (b)(4).The eval/investigation found the hf resection electrode with deformed fork tubes.Furthermore, the loop wire is damaged/broken and heavily deformed.Causal for this damage and the subsequent breakage of the loop wire is mechanical overload by the application of excessive force.Therefore, this incident was attributed to abnormal use/off-label use and the case will be closed from olympus side with no further actions.However, the incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results and pro re nata trained again on the correct usage of the olympus medical devices.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 AND IBE GMBH; kuehnstrasse 61; hamburg 2204 5; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 0669662955
• MDR Report Key: 4548065
• MDR Text Key: 5524046
• Report Number: 9610773-2015-00008
• 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: 01/27/2015

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: A22205D
• Device Lot Number: 13217P03L001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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