MAUDE Adverse Event Report: GYRUS ACMI ACMI; RESECTOSCOPE SHEATH, EMRS-24

Model Number EMRS-24

Device Problems Detachment Of Device Component (1104); Fracture (1260)

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

Event Date 02/03/2014

Event Type  malfunction  

Event Description

The 24 fr standard metal resectoscope sheath beak fractured.A portion, the distal portion broke off and was retrieved.

• Brand Name: ACMI
• Type of Device: RESECTOSCOPE SHEATH, EMRS-24
• Manufacturer (Section D): GYRUS ACMI; 136 turnpike rd; southborough MA 01772
• MDR Report Key: 3979933
• MDR Text Key: 4635725
• Report Number: MW5037589
• Device Sequence Number: 1
• Product Code: FDC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/20/2014

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: Health Professional
• Device Model Number: EMRS-24
• Device Lot Number: CE 0344
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1