MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH UNKNOWN - ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICA (FAS); RESECTION ELECTRODE LOOP

Model Number A22205D

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 03/29/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event could not be determined.As part of our investigation of this report, olympus made multiple attempts to obtain additional information regarding the reported event; however, no additional information was obtained.Although no model was provided, instruction manuals for resection electrodes contain several caution statements in an effort to prevent damage to the electrode.

Event Description

Olympus received a medwatch report on (b)(6) 2016 stating that during a cystoscopy with transurethral resection of the prostate, one of the resection electrode loops broke and was replaced without incident.There was no evidence of foreign bodies.The model and lot number of the device is unknown.The patient's outcome is unknown.

Manufacturer Narrative

This supplemental report is being submitted to update the model number of the reported device.

• Brand Name: UNKNOWN - ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICA (FAS)
• Type of Device: RESECTION ELECTRODE LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5708870
• MDR Text Key: 46891124
• Report Number: 2951238-2016-00496
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22205D
• Device Catalogue Number: A22205D
• Device Lot Number: 15320P03L001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2015
• 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