MAUDE Adverse Event Report: GYRUS ACMI INC. IGLESIAS WORKING ELEMENT

Model Number EIWE

Device Problems Sparking (2595); Flare or Flash (2942)

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

Event Date 04/30/2015

Event Type  malfunction  

Event Description

Olympus received a voluntary medwatch form, which stated "upon starting the case, the resectoscope was attached to electrical current and a large spark/flash was observed in/around the device near the patient and the physician's face.The procedure was a transurethral resection of prostate (turp)." olympus followed up with the user facility and it was reported that the disposable device used in the procedure was discarded, but the resection devices were taken to reprocessing.No further information was provided.This is one of three reports.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented accordingly.Please cross reference mfr report # 2951238-2015-00324 and 2951238-2015-00325.

• Brand Name: IGLESIAS WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4917364
• MDR Text Key: 6432280
• Report Number: 2951238-2015-00316
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/28/2015

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 Model Number: EIWE
• Device Catalogue Number: EIWE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MLE-24-012 LOT# UNK (B)(4); DAC/ELITE & USA DISPOSABLE ACTIVE CORD LOT# UNK
• Patient Age: 81 YR