MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH

Model Number A22040A

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

As part of the investigation, olympus followed up with the user facility to obtain additional information but with no results the legal manufacturer could not conduct a review of the device history records due to no lot number reported.Instead the manufacturing and quality control review was performed for the last 24 months of production without showing any non-conformities or deviations regarding the described issue.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

Olympus received a medwatch report (b)(4) via mail that states, "during the case while doing turbt(transurethral resection of bladder tumor) (blue light) the surgeon suddenly noticed a piece of gray foreign body inside the bladder, through the lens he noted a broken tip of the of the 24 fr resectoscope sheath (a22040a).Surgeon removed the broken piece (piece by piece) using an alligator forceps.Scrub nurse and charge nurse checked the pieces making sure it is complete.Surgeon made sure that he removed the remaining pieces so that there's nothing left in the bladder.Instrument was removed from the tray, tagged and sent to sterile processing department (spd)." no death or serious injury was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer.The investigation was completed by the legal manufacturer and determined that 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.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.Lost fragments of the ceramic insulation insert can be localized using a suitable x-ray procedure or computed tomography.As stated on the ifu and as a preventive measure, the user manual states: warning- risk of injury - impact, fall, shock or similar stress can damage the ceramic insulation at the sheath¿s distal end.Damaged instruments can cause injuries to the patient and/or user.Do not use the olympus will continue to monitor complaints for this device.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: INNER SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11322443
• MDR Text Key: 231789458
• Report Number: 9610773-2021-00075
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• PMA/PMN Number: K931995
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR