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

Model Number EIS-HCF25

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the device ceramic insulation at the distal end of the inner sheath was observed to be broken.Approximately, based on the returned broken device, 30 percent of the insulation tip broken off from the device and observed with sharp edge.The reported failure mode had been addressed by the original equipment manufacturer.Solid mechanics was identified as a contributor to ceramic tip fracture.Device history records for this product were reviewed and showed the product met all specifications upon release.This unit was produced after corrective actions were taken, and had a new design tip with a black ceramic material.Based on the device evaluation results, tip fracture occurred to the device could result from excessive force or moment applied during use.As a ceramic material is brittle in nature, ceramic tips are susceptible to fracture even though a robust re-design with a more durable material has been made.The instructions for use (ifu) states "always keep sheaths parallel to one another when assembling and disassembling.If the inner sheath is inserted or removed at an angle to the outer sheath, the lateral force applied to the inner sheath may crack, loosen, break, or otherwise damage the sheath¿s insulated distal tip.A broken tip, or fragments of a damaged tip, can potentially pass through the outer sheath and into the patient.If drag or resistance is encountered during assembly or disassembly, stop align working element and sheath parallel to one another before proceeding".Olympus will continue to monitor the field performance of this device.

Event Description

It was reported that during an unspecified procedure the device inner sheath broke inside the patient.The broken tip was retrieved.There were no further details provided regarding the event.There was no patient harm or injury reported.No user injury reported.

Event Description

Updated event reported: the event occurred during a diagnostic procedure.There were no other devices involved in the event.There was no delay.Patient was under general anesthesia.The procedure was completed with the same device.The tip fell into the patient's bladder.There was one piece.The patient was checked for injury.No x-ray or ct was performed.There was no sparking/arcing at the time of event.There was no patient bleeding.The patient did not require a longer stay or medical treatment.The device was inspected prior to use and no anomalies were observed.

Manufacturer Narrative

This supplemental report is being submitted to provide the customer updates/response.

• Brand Name: CF RESECTOSCOPE INNER SHEATH, 25FR
• Type of Device: CF RESECTOSCOPE INNER SHEATH, 25FR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10971743
• MDR Text Key: 242684126
• Report Number: 1519132-2020-00104
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EIS-HCF25
• Device Lot Number: CC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1