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

Model Number A22040A

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

The olympus repair inspection confirmed the customer¿s reported problem, the ceramic insulation at the distal tip of the sheath was found loose.No other defects were observed.The investigation is still in progress; 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.Additional 501(k): k931995.

Event Description

Olympus was informed via repair request, the customer inner sheath was returned to olympus for repair for a reported damaged ceramic insulation, ¿loose tip beak¿.The customer reported event was found at inspection before use.No death or injury and no impact to patient or other was reported to olympus.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the damaged ceramic tip was caused by thermal and mechanical induced wear and tear, improper handling, or mechanical overload such as a fall, shock or similar stress.Additionally, it cannot be determined whether the resection sheath had been previously damaged or if the damage on the ceramic insulating insert was caused during the last reprocessing or during last usage.The final root cause of this event was unable to be identified.The following is included in the instructions for use: ¿4 before use warning infection control risk 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.4.1 inspection and testing inspecting the product visually inspect the product.Make sure that it has: -- no corrosion -- no dents -- no scratches ceramic insulation at distal end visually inspect the ceramic insulation at the sheath¿s distal end before each use.Do not use the instrument in case of damage (e.G.Cracks, fractures).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 instrument if damaged.Damaged product if the product is damaged or does not function properly, contact an olympus representative or an authorized service center.¿ in case of an unknown location of the fragment, appropriate procedures such as x-ray methods or computer tomography can be used for localization and removing if necessary.Olympus will continue to monitor field performance 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, 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: 16583900
• MDR Text Key: 312123369
• Report Number: 9610773-2023-00822
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 19Y04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2019
• 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