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

Model Number ERIS-CF25

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

As reported, the resectoscope is missing the ceramic tip.The issue found during an unknown event.There is no patient involvement /harm or injury associated on this reported event.No user injury reported.

Manufacturer Narrative

The subject device was not returned for evaluation.The device photo provided shows that the ceramic tip of one sheath was completely missing.No other physical damage was observed from the photo.Multiple attempts has been made to gather additional information, however, were unsuccessful, no response received from the customer.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 - multiple attempts were made to identify the serial number but were unsuccessful.Therefore, device manufacture date is unknown.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.There has since been a design change, to remediate tip fracture, a design change in material and geometries of the tips has been implemented.The new tip material has been successfully validated for production release.Since the serial number of the reported device is unknown, it is unknown if the device has an old or newly designed ceramic tip.Based on the results of the investigation, the cause of the missing ceramic tip could not be determined at this time as the device was not returned for evaluation.The following information is stated in the instructions for use: " 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." olympus will continue to monitor field performance for this device.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: ROTATING 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: 12981376
• MDR Text Key: 290076834
• Report Number: 1519132-2021-00022
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925003484
• UDI-Public: 00821925003484
• 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: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/03/2022

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: Health Professional
• Device Model Number: ERIS-CF25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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