MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; 04042761020961

Model Number A22041A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 10/20/2021

Event Type  malfunction  

Event Description

The technical support engineer was informed by the materials manager at the user facility that the tip of the 24fr.Resection sheath broke apart in the patient's bladder during an unspecified procedure.The broken tip was retrieved from the patient.No patient injury was reported to olympus.No device will be returned as the device has been discarded by the user facility.

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.A review of the device history records could not be conducted for the concerned device as the lot number is unknown.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.No device was returned to the legal manufacturer; therefore, the exact cause of the reported issue could not be conclusively determined.Based on the investigation, the insulation tip's damage was caused by mechanical thermal influence.Unfortunately, it cannot be determined with certainty, whether there was a previous damage on the device or any damage on the ceramic insulating insert was caused during last reprocessing or during last usage as stated on the ifu (instructions for use manual) and as a preventative 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, properly reprocess the product before first and each subsequent use following the instructions in this manual and in the system guide endoscopy.Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel.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 instrument if damaged.If the product is damaged or does not function properly, contact an olympus representative or an authorized service center olympus will continue to monitor complaints for this device.

Event Description

The event occurred at the end of a urology case as the sheath was removed, the surgical technician noticed the tip of the sheath was broken and pieces of the material were in the patient.The pieces were successfully removed and the procedure was completed.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the materials manager at the user facility.The device will not be returned for evaluation as the device was discarded following the procedure.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: 04042761020961
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 12797089
• MDR Text Key: 283431569
• Report Number: 9610773-2021-00319
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN WORKING ELEMENT; UNKNOWN WORKING ELEMENT