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

Model Number ERIS-CF25

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the reported issue was confirmed.The ceramic insulation tip was found broken at the distal end side and a portion of the ceramic insulation tip (approximately 50%) broke off leaving sharp edges.The missing piece(s) were not returned for evaluation.Multiple scratches throughout the sheath were observed.The movement from the release button was found normal.The resectoscope found no issues when being inserted into the outer sheath.As stated on the ifu and as a preventive measure: 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.Based on evaluation findings, the reported failure was due to mishandling.

Event Description

It was reported that during reprocessing, the ceramic tip was found broken.There was no patient involvement on this report.No user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to inform that upon further review, this report is a duplicate of patient identifier report (b)(6), mfr1519132 - 2020 - 00070.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: ROTATING CF RESECTOSCOPE INNER SHEATH
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10596884
• MDR Text Key: 208975921
• Report Number: 1519132-2020-00080
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• 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: 11/05/2020

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: ERIS-CF25
• Device Lot Number: IC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1