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

Model Number A22040A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

As part of the investigation, olympus followed up with the user facility to obtain additional information regarding the reported event but with no results.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

On july 14, 2021, olympus received medwatch report# 5102227 which states: "during turp procedure the circular of the resectoscope, which is not detachable part of the instrument became dislodged and was retained in the patients bladder.At cystoscopy 2 months latter a small foreign object was noted in the bladder which was latter identified as the tip of the resectoscope." the reporter categorized as a malfunction and no adverse event.No device available for evaluation.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: g3, g6, h2, h6 and h10.A review of the device history record (dhr) could not be conducted due to the lot number is unknown or missing.However, the manufacturing and quality control review was performed for the last 24 months of production and there are no non-conformities or deviations regarding the described issue.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.Since no further information was reported and no device was returned, the root cause of the reported malfunction could not be conclusively determined.Based on the description, ¿ceramic tip broke in the bladder of the patient and remained there unnoticed.However, following a cystoscopy after two months, a foreign body was found in the bladder and later identified as the ceramic tip.¿ the potential cause of the insulation tip's damage was caused by mechanical thermal influence as damage of the insulation material of the sheath could be attributed to thermal mechanical overload, improper handling, mechanical impact like fall, shock or similar stress.Please note that signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.In the case of unclear remains of fracture fragments, of the insulating insert made of ceramic, these can be localised with a suitable x-ray procedure or computer tomography and removed, if necessary.As stated in the ifu (instruction for use) and as a preventive measure, the ifu carries a warning that the ceramic tip can break due to mechanical loading or thermally induced straining.Thus, it is the responsibility of the user to inspect the instrument prior to every procedure.Additionally, a suitable replacement device must be provided during an application.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, hamburg 22045 ; GM 22045
• MDR Report Key: 12291136
• MDR Text Key: 268689379
• Report Number: 9610773-2021-00219
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• PMA/PMN Number: K931994
• 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: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• 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: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1