MAUDE Adverse Event Report: GYRUS ACMI, INC. USA ELITE SYSTEM; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Catalog Number CE0344

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

Patient Problem No Information (3190)

Event Date 04/30/2015

Event Type  malfunction  

Event Description

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.

• Brand Name: USA ELITE SYSTEM
• Type of Device: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• MDR Report Key: 4787163
• MDR Text Key: 5876527
• Report Number: 4787163
• Device Sequence Number: 1
• Product Code: FED
• 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: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: CE0344
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THIS WAS A REUSABLE PRODUCT THAT HAD DISPOSABLE; ATTACHMENTS CONNECTED TO IT DURING THE PROCEDURE
• Patient Age: 81 YR