MAUDE Adverse Event Report: OLYMPUS WINTER AND IBE GMBH HF RESECTION 90 DEGREE ELECTRODE NEEDLE 24-28FR 12 DEGREES; RESECTION ELECTRODE

Model Number A22253C

Device Problems Thermal Decomposition of Device (1071); Fracture (1260)

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

Event Date 08/04/2014

Event Type  malfunction  

Event Description

Olympus was informed that during a therapeutic direct vision internal urethrotomy (dviu) of a bladder contracture, while performing the incision on the bladder neck, two separate devices burnt out at the beginning of the procedure.Both devices were replaced and the intended procedure was successfully completed with a third similar device.An inspection of the damaged devices showed a fractured colins knife tip.It was stated that the procedure was prolonged by thirty minutes.The physician stated that the patient's condition after the procedure was excellent.There was no patient injury reported.

Manufacturer Narrative

The device referred to in this report has not yet been returned to olympus for eval.The exact cause of the reported incident could not be conclusively determined at this time.If additional info becomes available at a later time, this report will be supplemented.

• Brand Name: HF RESECTION 90 DEGREE ELECTRODE NEEDLE 24-28FR 12 DEGREES
• Type of Device: RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER AND IBE GMBH; kuehnstrasse 61; hanburg 2204 5; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER AND IBE GMBH; kuehnstrasse 61; hamburg 2204 5; GM 22045
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131-1700 ; 4089355002
• MDR Report Key: 4093165
• MDR Text Key: 20325717
• Report Number: 2951238-2014-00318
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2014

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 Model Number: A22253C
• Device Catalogue Number: A22253C
• Device Lot Number: 13277P02L001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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: MFR REPORT # 2951238-2014-00317; MODEL # A22253C, SERIAL # (B)(4),
• Patient Outcome(s): Other
• Patient Age: 76 YR