MAUDE Adverse Event Report: GYRUS ACMI, INC. (OLYMPUS) ACMI USA ELITE SYSTEM AND USA SERIES RIGHT ANGLE CUTTING LOOP ELECTRO; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number MLE-24-012

Device Problem Bent (1059)

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

Event Date 07/19/2017

Event Type  malfunction  

Event Description

The part of the loop that the scope goes through was bent.Had to open a new one.

• Brand Name: ACMI USA ELITE SYSTEM AND USA SERIES RIGHT ANGLE CUTTING LOOP ELECTRO
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC. (OLYMPUS); 136 turnpike road; southborough MA 01772
• MDR Report Key: 6750239
• MDR Text Key: 81360411
• Report Number: 6750239
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• 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: 07/21/2017

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: No Information
• Device Expiration Date: 10/01/2018
• Device Model Number: MLE-24-012
• Device Catalogue Number: MLE-24-012
• Device Lot Number: 794571JF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1