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

Model Number EIS-HCF25

Device Problems Crack (1135); Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

As reported the device, its missing the black end of the tip on the end of it, cracked sometime during the procedure.Ceramic tip missing at end of case.Discovered by scrub tech in the cysto drapes.There is no patient harm or injury reported due to the event.No user injury reported.

Manufacturer Narrative

The device was received and evaluated.Inspection noted , the lot number is gc.The complaint was confirmed.It was observed that the insulating tip was broken off and damaged.The red dot on the shoulder screw was missing.There were no problems with the passage and locking.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.H4 - the device was manufactured in june 2019.A final device manufacturer date is not available.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the ceramic tip material is brittle in nature, user mishandling and/or stress applied during use may facture the ceramic tip which is likely the cause of the event.The following information is stated in the instructions for 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." olympus will continue to monitor field performance for this device.

Event Description

Customer updates on the event reported as below: the missing ceramic was located in the cysto drapes at the end of the procedure.The scrub technician noticed it was missing at the end of the case.Scrub tech found the missing tip in the cysto drapes in two separate pieces after it was noticed the tip was missing from resectoscope.No harm , no patient impact.Broken tip was not inside the patient.The doctor was notified tip found in drapes.The patient was checked (re-scope) to ensure no pieces were left inside the bladder.Nothing found inside the bladder.The intended procedure was completed.Procedure performed was tur-button turp (transurethral resection of the prostate).

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates.The following sections were updated: b5, e2, e3,g3, g6, h2, h6 and h10.

• Brand Name: CF RESECTOSCOPE INNER SHEATH, 25FR
• Type of Device: CF RESECTOSCOPE INNER SHEATH
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 93 north pleasant st.; norwalk, OH 44857 ; 9013785969
• MDR Report Key: 12981234
• MDR Text Key: 283616616
• Report Number: 1519132-2021-00021
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925001893
• UDI-Public: 00821925001893
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2022

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: Lay User/Patient
• Device Model Number: EIS-HCF25
• Device Lot Number: GC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 12/13/2021; 12/28/2021
• Supplement Dates FDA Received: 12/28/2021; 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2019
• 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