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

Model Number A22041A

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)

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

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

The olympus fse noted reported the lot number of the subject device has been washed off and is not legible but the item will be returned to olympus for service to attempt to retrieve the lot number.The investigation is still ongoing; however, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.

Event Description

The olympus (omsi) field service engineer (fse) was informed by the customer, during maintenance, the customer resection sheath was inspected and found to have a broken ceramic insulation beak at the sheath¿s distal tip.No patient or procedure was involved.The olympus fse noted reported the lot number of the subject device has been washed off and is not legible but the item will be returned to olympus for service to attempt to retrieve the lot number.

Manufacturer Narrative

Additional information: d4 - lot number, h4 - device manufacturer date; device evaluation: the suspect medical device was not returned to the manufacturer for investigation/evaluation but to olympus medical systems india (omsi) (returned to omsi on 2023/02/10).The evaluation at omsi confirmed that the ceramic insulation beak at the distal tip of the resection sheath had broken off.The cause of this damage is most likely thermo-mechanical fatigue and/or mechanical overload, possibly as a result of excessive force such as impact, fall, shock or similar stress in combination with wear and tear.Therefore, this event/incident was attributed to use error.It cannot be conclusively determined whether the insulating insert had already been pre-damaged before the incident occurred, whether the damage was triggered during the reprocessing cycle preceding the incident, or during the last procedure.A material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the resection sheath without showing any abnormalities.The evaluation at omsi also found the sealing ring to be damaged and the sheath to be scratched.These issues are most likely attributable to wrong handling by the user and to wear and tear.The case will be closed on olympus side with no further actions and the user will be informed about the investigation results.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTION SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16383763
• MDR Text Key: 309761141
• Report Number: 9610773-2023-00514
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

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: 186W-0066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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