MAUDE Adverse Event Report: GYRUS ACMI, INC ROTATING CF RESECTOSCOPE INNER SHEATH; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	ERIS-CF25
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation (it was discarded by the customer).The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported the patient underwent a transurethral resection of a bladder tumor (turbt) using an eris-cf25 rotating cf resectoscope inner sheath for the indication of bladder cancer.There were no challenges with the patient's anatomy.There were no known complications during this procedure.Four months and 17 days later, the patient underwent a second planned turbt using an eris-cf25 rotating cf resectoscope inner sheath for the indication of bladder cancer.During the second turbt procedure, two device fragments from what appeared to be the eris-cf25 rotating cf resectoscope inner sheath used in the first procedure were found.The device fragments were removed from the patient without issue or delay in the planned procedure.The physician stated there were no adverse effects to the patient as a result of the retained fragments.
Additional Manufacturer Narrative
This report is being updated to report investigation findings.Per clinical assessment, the complaint is determined to be a reportable device malfunction since there is a potential for retained device fragments to cause or contribute to a serious injury should this malfunction recur.The device was discarded, and the lot number was unknown.Dhr review was not conducted due to an unknown lot number.The reported failure mode had been addressed by the oem.In (b)(6) 2014, to remediate tip fracture, a design change to the eris-cf25 tips with a more durable material has been implemented.The new tip material has been successfully validated for production release.Since the lot number of this complaint device was unknown, it was unable to know if the device has a previously or newly designed tip.As a ceramic material is brittle in nature, all ceramic tips are susceptible to fracture even though a more robust re-design has been implemented.Potential damage to distal tip during use is addressed in the device ifu with warning given on page 14, "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." conclusion: the definitive cause of the user's experience can not be established.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11717789
• Report Number: 1519132-2021-00009
• Device Sequence Number: 17085108
• Product Code: FAS
• UDI-Device Identifier: 00821925003484
• UDI-Public: 00821925003484
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K890328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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
• Operator of Device: Health Professional
• Device Model Number: ERIS-CF25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 101