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

Model Number ERIS-CF25

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a therapeutic procedure, the device tip broke off inside the patient bladder.The tip was retrieved with no harm to the patient.The device used to retrieve the broken tip was not provided.No impact or injury reported on this reported event.

Manufacturer Narrative

This supplemental report is being submitted to provide the customer response/updates and review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Device evaluation is not available as the customer will not be returning the device.An investigation was completed by the original equipment manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause cannot be determined as the device was not returned for evaluation.Olympus will continue to monitor the field performance of this device.

Event Description

No further medical intervention was required and the patient is stable.The tip was removed with the grasper device of a cystoscope.No photos of the device are available.The procedure being performed was a therapeutic, transurethral resection of prostate.The procedure was completed with a new resectoscope, lot number unknown.The customer cannot provide if this occurred during the beginning, middle or end of the procedure.The device was inspected prior to the procedure.No damage or abnormalities were observed.The damaged tip is being kept at the user facility.The device will not be returned to olympus as their policy is to keep the device at their organization and not release it back to the manufacturer.A user reported medwatch was filed that stated "required intervention to prevent permanent impairment/damage" however, it did not report a serious injury and there was only one device involved.

• 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: 10489772
• MDR Text Key: 208370693
• Report Number: 1519132-2020-00065
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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: GD
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 107