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

Model Number EIS-CFR-25

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has not yet been returned to the service center for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.

Event Description

The service center was informed that during therapeutic transurethral resection of the prostate (turp) procedure, the sheath was inserted into the patient and the tip broke off.The device fragment was successfully retrieve from the patient.The intended procedure was completed with a similar device.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results.Please the updates in sections:d10, g4, g7, h2, h3, h4, h6 and h10.The customer returned the eis-cfr-25 resectoscope inner sheath (lot fw) for evaluation due to ¿the tip broke off¿.The user¿s complaint has been confirmed.A visual inspection was performed on the received device and found the ceramic insulation at the distal end of the inner sheath broken; missing piece(s) not returned for evaluation.An estimate of, 50 percent of the insulation tip is missing from the device.Additionally, the broken portion of the ceramic sheath is not protruding out from the inner sheath.The instructions for safe use (ifu) states the following; ¿do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.Damage may result in the loss of the entire ceramic tip or fragments of the ceramic tip.Based on the evaluation, the likely cause of the broken ceramic insulation tip is due to mishandling.The portion of the ceramic tip that was broken off, was not returned for evaluation.The dhr review of the eis-cfr-25 inner sheath (date code fw) manufactured june 2016, did not find any defects, nonconforming issue or any corrective action issues during the assembly build of the device.All records indicate the device was manufactured in accordance with all applicable procedures and final product release criteria.

• Brand Name: USA ELITE CF RESECTOSCOPE INNER SHEATH, 25FR
• Type of Device: INNER SHEATH
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9466185
• MDR Text Key: 182775839
• Report Number: 2951238-2019-01222
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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: FW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1