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

Model Number A22041A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

The inner sheath was returned, however, the physical inspection and the investigation are in progress.If additional information becomes available, this report will be supplemented accordingly.

Event Description

On september 17th, 2020, olympus received a medwatch form via email, that stated, "during mid-portion of case the resectoscope was not working properly, the tip of the inner sheath had come loose and dislodged into the patient's bladder.The resectoscope was removed, cystoscope passed per urethra to the bladder and using rigid graspers removed the inner sheath tip without difficulty.When inspected, tip was intact.No injury to patient." no report number on medwatch form.The procedure was a transurethral resection of the prostate.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr# 9610773-2020-00236.A physical evaluation was performed on the subject device.The evaluation found that the remaining portion of the beak had jagged edges but was still securely adhering inside the sheath.The broken piece had one long deep crack, scratch, and biomaterial inside, and that there was evidence of glue remnants on the broken beak indicating the beak had been glued properly.No fragment appeared to be missing and the tip of the inner beak was not loose but broken off due to force.It is unknown if there was (undetected) previous damage to the insulation insert or if it was already worn, and if the damage was caused during the last preparation cds (cleaning, disinfection and or sterilization) of the instrument or during its last use in a procedure.The oem performed a device history record review and no abnormalities were found.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on similar complaints, the oem determined the reported 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.On several shafts, the ceramic inserts broke during the procedure or during reprocessing.As a result, the oem has an open action for the insulation insert long term stability olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-00236.The risk management data specialist at the user facility further reported there was no other devices involved or replaced during this event.The subject device had dislodged in the middle of the procedure.The procedure was completed with a different device (model and serial number of the replacement device not provided).There was no injury involved in this event.The device was inspected prior to use and no abnormalities were found.A cystoscope was used to identify the fragments.The investigation is ongoing.If additional information becomes available, this report will be updated accordingly.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTION SHEATH, 24 FR.
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10657142
• MDR Text Key: 225395541
• Report Number: 9610773-2020-00236
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• 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: 197W-0095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 62