MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.

Model Number A22041A

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

The legal manufacturer performed a review of the device history records for the concerned device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The device was not returned.Therefore, the root cause of the reported malfunction cannot be determined at this time.However, the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The nurse at the user facility reported, during a therapeutic cystoscopy with laser lithotripsy of the bladder stone procedure, a piece of the resection sheath broke off into the bladder of the patient.The ellic evacuator was used to retrieve the broken pieces from the patient.It was flushed out with water and all pieces were accounted for.There was no delay in the procedure and the intended procedure was completed using the same device.The device was inspected prior to use.No deep impact was sustained to the device.There was no patient injury associated with this event.

Manufacturer Narrative

The customer returned the subject device to the service center.The evaluation confirmed a portion of the black colored insulation tip was broken off and missing.The device was repaired to specification and returned to the customer.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The legal manufacturer determined the damage to the insulation insert was most likely caused by thermo-mechanical fatigue / wear and tear.Another possible cause is improper handling by the customer, more specifically the device being subjected to mechanical overload, impact, accidental dropping, etc.As a general note, cracks on the insulation material are mostly not visible, making visual inspection difficult.It is unknown if there was pre-existing damage to the insulation insert or if it was already worn.Furthermore, it cannot be determined if the damage was caused during the last reprocessing of the instrument or during its last use in a procedure.In this case, the fragment was successfully removed from the patient's bladder.Lost fragments of the ceramic insulation insert can be localized using a suitable x-ray procedure or computed tomography.Olympus will continue to monitor complaints for this device.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTION SHEATH, 24 FR.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11284703
• MDR Text Key: 242233515
• Report Number: 9610773-2021-00070
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: 19YW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK MEDICAL URETERAL CATHETER REF.021305-G14521.; FLEXIVA 550 M0068403931 LASER FIBER,; LUMENS POWER SUITE VERSAPULSE 20W SN:(B)(6)
• Patient Age: 49 YR
• Patient Weight: 166