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

Model Number E2IS-CF25

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the customer's experience can not be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation, or upon receipt of additional relevant information.

Event Description

Olympus received voluntary mw#: (b)(4) on 24nov2020.In this report the following information was reported by the customer: in october 2020 (precise date not provided), during a cystoscopy and fulguration of bladder bleeding, and turbt, a piece of a surgical instrument was found in bladder of a patient from a previous surgery.It was successfully broken up into several pieces, removed and sent to pathology.The piece was believed to be from the end piece of a resectoscope sheath.Upon inspection of the resectoscope that was used on the patient, it was discovered that the end piece of the sheath was missing.Additional information provided by the customer upon request clarified the ceramic tip of the device broke off into the patient at one facility, and was removed at a different facility during another procedure.The patient did sustain mild urethral trauma of the prostatic urethra upon removal of a device fragment.Although requested, no information was provided regarding required treatment.The patient's current condition is reported as stable.

Manufacturer Narrative

This report is being submitted to report investigation findings.D4: lot number: unknown.The device history record (dhr) review for this device could not be performed as the lot number is unknown.The reported failure mode has been addressed by the legal manufacturer.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.It is unknown if this complaint device had been through the corrective action since the device was not returned for evaluation and the lot number is unknown.A potential damage to distal tip during use is addressed in the device ifu with warning given on page 14, "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." conclusion: the definitive cause of the reported event could not be established.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11049673
• MDR Text Key: 223719595
• Report Number: 1519132-2020-00108
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

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: E2IS-CF25
• Device Lot Number: 344
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1