MAUDE Adverse Event Report: GYRUS ACMI, INC CF RESECTOSCOPE INNER SHEATH, 25FR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number EIS-HCF25

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

Due diligence was executed for this event.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date is not known.The user¿s complaint was confirmed.A visual inspection was performed on the as is received condition of the device; observed that the ceramic tip on the distal end of the device is broken.A portion of the ceramic tip was broken off on the inner sheath, and was not returned for evaluation.Minor scratches were found through the sheath however the scratches did not leave sharp edges.The device was connected to a test working element, and was able to securely attach and lock with no issues.The release button on the device was functioning properly when the test working element was removed.The instructions for use (ifu) include the following: ¿do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.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." warning: 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 the evaluation the most possible cause for the broken ceramic tip could be attributed to user mishandling.

Event Description

As reported for this event, during the diagnostic transurethral resection of bladder tumor (turbt) procedure the tip of the device broke off into the doctor¿s hand as the doctor was pulling the sheath from the patient to retrieve the specimen.The intended procedure was completed with no delays with the same device as the event occurred after the completion of the procedure.There was no patient injury, or medical intervention required.The device was inspected prior to use.There were no anomalies observed during the inspection.There was no metal protruding.The device is reprocessed manually.The scope is being autoclaved temperature exposure time at 270 degrees at 4 minutes/20 minutes dry.The device is being stored in a peel packed separately.There were no issues withdrawing, or inserting the scope into operating room from the patient.No excessive force was used for the tip to break off.No other devices were involved in this event.

Manufacturer Narrative

There is a correction information being provided: this device is controlled by a lot # not submitted in the initial mdr.This lot # is ¿cc¿.There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that the deice was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of 6 units were produced under this lot number with no associated ncrs, reported scrap or recorded process deviations relating to the reported failure.A review of instrument history could not found any records indicating that the unit had been sent in for service before.To remediate tip fracture, a new design of the tips has been implemented.The new tip material has been successfully validated for production release.This device has the newly designed tip.The instructions for use also includes the following statements: "study this manual and other labeling thoroughly for safe handling, storage and usage, including instructions for all generators and accessories".

• Brand Name: CF RESECTOSCOPE INNER SHEATH, 25FR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10626883
• MDR Text Key: 209825159
• Report Number: 1519132-2020-00085
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EIS-HCF25
• Device Lot Number: CC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 87