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

Model Number ERIS-CF25

Device Problem Break (1069)

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

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The root cause of the reported event could not be conclusively determined at this time; however, based on similar reported events the operator¿s technique during the use of the device could not be ruled out as a contributing factor to the reported event.The instruction manual provides warning and caution statements in an effort to mitigate the risk of patient harm and equipment damage which states, ¿examine this device prior to use.Do not use if damage is found.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.¿.

Event Description

Olympus was informed that during the middle of a transurethral resection of a prostate procedure, plastic pieces at the distal tip of the sheath broke off and fell into the patient¿s bladder.Three pieces were suctioned out of the patient with irrigation.The procedure was delayed by thirty minutes.The intended procedure was completed using the same device.There was no patient injury reported and there was no additional procedure/treatment was required.In addition, the device was inspected prior to procedure with no anomalies observed.The device is reprocessed utilizing steam sterilization (autoclave).

Manufacturer Narrative

The device was returned to olympus for a physical evaluation.A visual inspection of the as received condition found the black colored ceramic insulation tip at the distal end of the device was broken and missing.A microscopic inspection revealed that the adhesive is still present inside the distal area where the insulation tip is attached.The remaining portion of the insulation tip inside the device has minor cracks and jagged edges.In addition, there are multiple scratches at the distal tip of the device, small deep indentations along the outer shaft tube and the red orientation dot on the shoulder screw is missing.However, the device passed the functional tests as the locking ring, release button and scope passage work appropriately.

• 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: 7631495
• MDR Text Key: 112576944
• Report Number: 2951238-2018-00370
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ERIS-CF25
• Device Catalogue Number: ERIS-CF25
• Device Lot Number: IW
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1