MAUDE Adverse Event Report: GYRUS ACMI, INC CF RESECTOSCOPE INNER SHEATH, 25FR

Model Number EIS-HCF25

Device Problem Break (1069)

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

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.A visual inspection was performed on the returned device and found 90 percent of the ceramic beak from the distal end broken off and missing.The broken ceramic beak was not returned for evaluation.There is a small portion of the ceramic beak still intact at the inner portion of the sheath.Further inspection found severe dents on the outer tube at the distal end where the breakage occurred.Additionally, there were multiple dents and scratches noted throughout the whole outer tube.Based on the investigation findings, the broken/missing ceramic beak and dents on the outer tube are due to impact damage attributed to mishandling.The instruction manual for use states, "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.".

Event Description

Olympus was informed during a therapeutic transurethral resection of bladder tumor (turbt) procedure, the plastic tip of the inner sheath broke off and fell into the patient¿s bladder.The device fragment was retrieved completely with a grasper.There was no unusual bleeding observed.It was reported that the doctor was resecting the tumor, when the breakage occurred.No x-ray was performed.No resistance was felt upon insertion of the device and no force was applied or required.The intended procedure was completed with a similar device.There was no patient injury reported.Additionally, the user facility reported that the sheath was inspected prior to use and no anomalies found.There were no issues noticed with the alignment and connection of the sheath when it was laid out in preparation for the procedure.The storage environment does not have heavy light exposure.The devices are stored in a room with no windows with normal inside lighting.

• Brand Name: CF RESECTOSCOPE INNER SHEATH, 25FR
• Type of Device: RESECTOSCOPE INNER SHEATH, 25FR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8380685
• MDR Text Key: 140653870
• Report Number: 2951238-2019-00477
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• 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: FM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 51 WK