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

Model Number EIS-CFR-25

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The exact cause of the reported event could not be determined at this time.However, based on similar events the most probable cause of the reported event could be attributed to the operator¿s technique.The instruction manual provides warning to mitigate the risk of patient harm and device damage which states, ¿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.¿.

Event Description

Olympus was informed that during a therapeutic resection procedure, the ceramic sheath broke and fell into the patient.The device fragment was retrieved.There was no unexpected bleeding reported.The patient did not require any additional procedures or hospitalization.The procedure was prolonged by approximately 15 minutes.The intended procedure was completed.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to report additional information.Additional review of manufacturing and production records show that the that the ceramic material switched better fracture toughness, elasticity modulus, flexural strength, heat shock resistance, and thermal conductivity.Eliminated the holes as stress concentrators.Eliminated the contact between the metallic tube and the ceramic tip (dimple into hole.) the new ceramic tip resists better to chipping caused by drops, bending/torque/tension stress, and thermal differential.The new material formulation is not marred by the current material¿s propensity to low temperature degradation leading to microcracking.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation, provide the device lot number and manufacturer date.Please see the updates to sections: d4, d10 g4, g7,h2, h3,h4, h6 and h10.The device was returned to the service center for evaluation.The black beak was found to be partially broken and the broken piece was missing, not returned.The beak is at a 30 degree angle and in the cylinder shape; therefore, the missing fragments could be variable in length, and approximately 40 percent of the beak is missing.Also found the red dot of release button missing.Visual inspection of the damaged beak under a microscope revealed jagged edges and multiple scratches on the beak.However, the remaining portion of the beak adhered firmly to the distal shaft.Furthermore, the device passed mechanically inspection as its lock ring and release button function correctly when checked with the test working element eiwe.

• Brand Name: USA ELITE CF RESECTOSCOPE INNER SHEATH, 25FR
• Type of Device: INNER SHEATH, 25FR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8502196
• MDR Text Key: 141590413
• Report Number: 2951238-2019-00728
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EIS-CFR-25
• Device Lot Number: AB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1