MAUDE Adverse Event Report: GYRUS ACMI, INC CF RESECTOSCOPE INNER SHEATH, 27FR

Model Number EIS-HCF27

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned for evaluation for the reported "ceramic tip broke off".The evaluation confirmed the ceramic tip was broken off as a visual inspection of the device found the black ceramic insulation tip (beak) was missing and not returned.The remaining portions of the beak inside the distal end has jagged edges indicating the tip had broken off.However, there is evidence of adhesive remains inside the distal sheath which indicates the beak being glued properly.Furthermore, multiple deep dents and scratches were found along the outer tube of the sheath.Mechanically, the device passed inspection as the lock ring, release button function, and passage function appropriately.Based on the evaluation findings, the sharp jagged edges on the remaining beak inside the sheath, including the dents and scratches on the outer tube, are an indication of physical damage due to impact or stress.To mitigate the risk of device tip damage the instruction manual cautions, "if applying excessive force on the instrument during insertion or removal or hitting the tip against other instruments will cause the insulation tip to break." in addition, "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." as a preventive measure, the instruction manual provides indicates prior to operation, to feel the entire surface of the instrument for dents, protrusions, or other irregularities¿do not use if damage is found.

Event Description

The manufacturer was informed that during hysteroscopy with polypectomy procedure, the black ceramic tip at the distal end of the sheath broke off and fell inside the patient as it was observed next to the patient's polyp.The broken tip was retrieved by the surgeon.The intended procedure was completed with no additional procedures.No patient injury was reported.It was noted the device was put together prior to procedure and there was no damage but the user facility noted that the shaft of the sheath had a dent.

• Brand Name: CF RESECTOSCOPE INNER SHEATH, 27FR
• Type of Device: CF RESECTOSCOPE INNER SHEATH
• 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: 9169041
• MDR Text Key: 204559339
• Report Number: 2951238-2019-01148
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2019

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: EIS-HCF27
• Device Lot Number: RXMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/08/2019
• 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