MAUDE Adverse Event Report: ACMI/OLYMPUS ACMI; CONTINUOUS FLOW RESECTOSCOPE

Catalog Number ACMI EROS-CF25

Device Problems Component Falling (1105); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 09/18/2017

Event Type  malfunction  

Event Description

A 25 french resectoscope tip broke during a procedure, and the pieces of the plastic tip fell into the patient's bladder.All three pieces of the plastic tip were removed from the patient by the surgeon, and the adjacent areas were inspected for trauma.None was noted.

• Brand Name: ACMI
• Type of Device: CONTINUOUS FLOW RESECTOSCOPE
• Manufacturer (Section D): ACMI/OLYMPUS; center valley PA 18034
• MDR Report Key: 6961178
• MDR Text Key: 89852595
• Report Number: MW5072840
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/17/2017

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: Health Professional
• Device Catalogue Number: ACMI EROS-CF25
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 154