MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS ELECTRODE LOOP

Model Number WA22603D

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2015

Event Type  malfunction  

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the surgeon buried the loop into the tissue that was meant to be resected.As the surgeon was performing the procedure, the loop electrode completely separated from the electrode body.The surgeon was unable to find the broken piece so she irrigated the bladder and believes that the fragment came out at that point.The intended procedure was completed with the same resection instruments with another similar loop electrode.There was no patient injury reported.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The exact cause of the user's experience cold not be conclusively determined as the user facility discarded the device.If additional information becomes available at a later time, a supplemental report will be submitted.

• Brand Name: OLYMPUS ELECTRODE LOOP
• Type of Device: ELECTRODE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho; hachioji-shi tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4083955002
• MDR Report Key: 4645316
• MDR Text Key: 5686049
• Report Number: 2951238-2015-00134
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22603D
• Device Catalogue Number: WA22603D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2015
• 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