MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS; RESECTION ELECTRODE

Catalog Number A22206C

Device Problem Sparking (2595)

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

Event Date 05/26/2015

Event Type  malfunction  

Event Description

Device was sparking.
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manufacturer response for resectoscope, (brand not provided) (per site reporter).
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emailed rep with product information.

• Type of Device: RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 3500 corporate pkwy.; center valley PA 18034
• MDR Report Key: 4843623
• MDR Text Key: 5871506
• Report Number: 4843623
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/26/2015

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: Physician
• Device Catalogue Number: A22206C
• Device Lot Number: 14118P02L001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2015
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 91