MAUDE Adverse Event Report: GYRUS ACMI, INC ROTATING CF RESECTOSCOPE INNER SHEATH; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number ERIS-CF25

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned for evaluation.The customer¿s complaint was not confirmed.No findings available.The cause could not be determined.No further information was reported.

Event Description

The customer reported to olympus that during a therapeutic, transurethral resection of bladder tumor procedure, the distal tip fell off into the patient.The distal tip was retrieved out of the patient.There was no patient injury reported.

Manufacturer Narrative

The device history record review of the eris-cf25 serial/lot number jc was shipped, manufactured october 2019, 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.A visual inspection on the received condition and found the ceramic insulation tip broken off at the distal end side.A large portion of the insulation tip (approximately 70%) was broken off; the missing piece(s) were not returned for evaluation.Additionally, an indentation was observed near the middle of the sheath.Further noted that, some of the labeling/identification was fading, but still legible.The movement from the release button was normal.The resectoscope had no issues when being inserted into the outer sheath.The root cause cannot be determined.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

Upon further review, this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10270886
• MDR Text Key: 208335290
• Report Number: 1519132-2020-00030
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• 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: JC
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1