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

Model Number ERIS-CF25

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the device was found with broken beak.The sheath insulating tip was observed to be broken and damage.The device was placed for repair.Based on the evaluation findings, the reported issue was confirmed.The root cause of the failure is unknown.Likely probable cause could be due to handling issue.

Event Description

It was reported that the device was found with broken ceramic tip.There were no further details provided regarding the event.No patient involvement reported.No user harm or injury reported.

Manufacturer Narrative

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

Event Description

Customer reported that the event was found after reprocessing.No other additional information provided.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr) and updated lot number.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.The reported failure likely attributed from excessive force being applied or a physical impact having occurred to the device during reprocessing.As stated on the ifu (instruction for use) the user manual states: damage may result in the loss of the entire ceramic tip or fragments of the ceramic tip.If there is evidence of charring, burn spots, chips or cracks in the ceramic tip or surrounding area, do not use.Study the manual and other labeling thoroughly for safe handling, storage and usage, including instructions for all generators and accessories and do not drop instruments, or allow them to be struck by other objects.Olympus will continue to monitor complaints for this device.

• 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: 10586068
• MDR Text Key: 216967591
• Report Number: 1519132-2020-00079
• 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,Followup
• Report Date: 11/04/2020

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: RXFB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 09/28/2020; 10/27/2020
• Supplement Dates FDA Received: 10/19/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1