MAUDE Adverse Event Report: GYRUS ACMI, INC. ELITE 2 SYSTEM CONTINUOUS FLOW RESECTOSCOPE INNER SHEATH 25.6 FR; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number E2IS-CF25

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/21/2020

Event Type  malfunction  

Event Description

Found a piece of a surgical instrument in bladder from previous surgery.It was successfully broken up into several pieces, removed and sent to pathology.The piece was believed to be from the end piece of the resectoscope sheath.Upon inspection of the resectoscope that was used on the patient, it was discovered that the end piece of the sheath was missing.

• Brand Name: ELITE 2 SYSTEM CONTINUOUS FLOW RESECTOSCOPE INNER SHEATH 25.6 FR
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana ave north; brooklyn park MN 55445
• MDR Report Key: 10851365
• MDR Text Key: 216604981
• Report Number: 10851365
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2020

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: E2IS-CF25
• Device Catalogue Number: E2IS-CF25
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2020
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other