MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Catalog Number WA22603D

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

The loop tip was found to be bent out of shape when the package was opened.The package had no visible damage.Manufacturer response for 24fr loop electrode, (brand not provided) (per site reporter).
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took description of the problem, issued rga#.Will issue credit.

• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 3500 corporate parkway; center valley PA 18034
• MDR Report Key: 4501380
• MDR Text Key: 5333458
• Report Number: 4501380
• Device Sequence Number: 1
• Product Code: FAS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: WA22603D
• Device Lot Number: 987856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2015
• Patient Sequence Number: 1
• Patient Age: 73 YR