MAUDE Adverse Event Report: GYRUS ACMI, INC. ROTATING CF RESECTOSCOPE INNER SHEATH; HYSTEROSCOPE (AND ACCESSORIES)

Model Number ERIS-CF25

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

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

There have been 2 occurrences reported by the customer with the ceramic tip falling off during procedure.This report is the 2nd occurrence.The olympus employee reported on behalf of the customer that the ceramic tip of the rotating cf resectoscope inner sheath broke and fell inside the patient body during a procedure.Additional customer follow-up has not been provided for patient outcome and procedural details.No patient or user injury was reported.1)patient identifier # (b)(6) rotating cf resectoscope inner sheath model; eris-cf25, serial # unknown 2)patient identifier # (b)(6); rotating cf resectoscope inner sheath, model # eris-cf25, serial # unknown (this report).

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.

Event Description

Additional information received identified that the ceramic tip fell into the patient's bladder/prostate.The procedure was a transurethral resection.The ceramic tip was retrieved with a grasper.A procedural delay was reported but the time of delay is unknown.It's unknown if additional anesthesia was required during the procedure.The procedure was completed with a different device.No additional medical/diagnostic interventions were undertaken to investigate the fallen device.By the visual inspection of bladder and broken piece, it was ensured that the device was completely retrieved, and no broken part left inside the patient.The patient did not experience any adverse effects or complications.The current condition of the patient, the outcome due to the procedure, and relevant preexisting conditions of the patient are unknown.Also, the patient demographics are unavailable.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, due to no device return, the complaint could not be confirmed.Therefore, the root cause of the reported failure cannot be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: "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." this supplemental report includes a correction to d4, e1 and g2 from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17969838
• MDR Text Key: 326125823
• Report Number: 3011050570-2023-00159
• Device Sequence Number: 1
• Product Code: HIH
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2023

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 10/25/2023; 11/09/2023
• Supplement Dates FDA Received: 10/26/2023; 11/16/2023
• 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): Other