MAUDE Adverse Event Report: GYRUS ACMI, INC USA ELITE CF RESECTOSCOPE INNER SHEATH, 25FR; ADULT RESECTOSCOPE

Model Number EIS-CFR-25

Device Problem Break (1069)

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

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation., therefore the cause of the reported event cannot be determined.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, when the sheath was inserted into the patient, the tip broke off inside the patient which they were able to successfully retrieve.The intended procedure was completed and the reported sheath was not used to complete the procedure.No other equipment was replaced during procedure.No patient injury reported.

Manufacturer Narrative

The customer returned eis-cfr-25 resectoscope inner sheath (lot ab) was evaluated due to ¿tip broke off¿.The user¿s complaint has been confirmed.Visual inspection on the received condition was performed.Evaluation determined that the ceramic insulation at the distal end of the inner sheath was broken, the missing piece(s) was not returned for evaluation.The missing portion is estimated to be 20 percent.In addition, it was observed that the broken portion of the ceramic sheath produced a sharp edge.Based on the evaluation, the most probable cause of the broken ceramic insulation tip is related to mishandling.

• Brand Name: USA ELITE CF RESECTOSCOPE INNER SHEATH, 25FR
• Type of Device: ADULT RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9597472
• MDR Text Key: 200858905
• Report Number: 2951238-2020-00317
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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: EIS-CFR-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1