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

Model Number ERIS-CF25

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/08/2022

Event Type  Injury  

Event Description

Olympus received a facility voluntary medwatch reporting; during a cystoscopy with transurethral resection of bladder tumor, blood clot evacuation procedure using a rotating cf resectoscope inner, sheath, the sheath was in patient, the doctor went to put the resectoscope in, and the white tip broke off in the sheath.All broken pieces from the resectoscope were accounted for.There were no reported adverse effects to the patient as a result of this occurrence.Additional details regarding the patient and reported event have been requested.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation (although it is expected to be).The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

Update: new information provided by the customer: the device has not been returned to olympus for evaluation.The tip actually broke off prior to the sheath being inserted into the urethra.There were no adverse effects to the patient as a result of this occurrence.There were no procedural or anatomical challenges that could have contributed to the reported event.The patient's current condition was not provided when asked.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record could not be performed, as the lot number of the device could not be determined.Based on the results of the investigation, a definitive root cause could not be established.Due to no device return, the suggested phenomenon could not be confirmed, and the root cause of the could not be further presumed.In march 2014, 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.As the lot number of the complaint is unknown, it is unknown if the device has an old or newly designed ceramic 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 (instructions for use, rev 99-1033_fk).The ifu 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.If drag or resistance is encountered during assembly or disassembly, stop¿align working element and sheath parallel to one another before proceeding." (section 4.0 assembly/disassembly, page 14).Per the risk assessment performed by product quality engineer, there will be no further actions taken in response to this complaint since olympus has taken the corrective actions to minimize the occurrence of tip fracture, and the occurrence of sheath tip fracture is within the expected values from the dfmea (design failure mode and effect analysis) for both the family and the specific model.Olympus will continue to monitor the field performance of this device.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15825196
• MDR Text Key: 303910305
• Report Number: 3003790304-2022-00302
• Device Sequence Number: 1
• Product Code: FAS
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 11/23/2022; 02/12/2023; 03/15/2023
• Supplement Dates FDA Received: 11/28/2022; 03/09/2023; 03/15/2023
• 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
• Patient Outcome(s): Required Intervention