MAUDE Adverse Event Report: GYRUS ACMI, INC. ERIS-CF25 SHEATH SET; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number ERIS-CF25

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2022

Event Type  malfunction  

Event Description

Sheath was in patient, doctor went to put the resectoscope in, white tip broke off in the sheath.All broken pieces from the resectoscope were accounted for.

• Brand Name: ERIS-CF25 SHEATH SET
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• MDR Report Key: 15672543
• MDR Text Key: 302423114
• Report Number: 15672543
• 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: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ERIS-CF25
• Device Catalogue Number: ERIS-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: 10/20/2022
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1