MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS

Model Number A42011A

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 05/11/2023

Event Type  malfunction  

Event Description

The customer returned the device for inspection with no specific fault (complaint) reported.Device return inspection found the ceramic tip was detached on the resection sheath.There was no patient injury.No harm was reported.This report is being submitted due to the finding of damaged ceramic tip identified during device evaluation.

Manufacturer Narrative

The subject device was evaluated.Device evaluation found the ceramic tip was detached on the resection sheath.Service repair noted the tension ring was once repaired by a 3rd party.The device evaluation also found that the sealing ring was broken.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction to h4.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the damage to the insulation insert was induced thermally and/or mechanically.Therefore, it is most likely attributable to wear and tear and/or improper handling by the customer (more specifically the device being subjected to mechanical overload, impact, accidental dropping, etc.).The event can be detected/prevented by following the instructions for use which state: ¿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.¿ olympus will continue to monitor field performance for this device.

• Brand Name: RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR. OUTER SHEATH, ABS
• Type of Device: RESECTION SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 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: 17101195
• MDR Text Key: 317766642
• Report Number: 9610773-2023-01610
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761023658
• UDI-Public: 04042761023658
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

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: Other
• Device Model Number: A42011A
• Device Catalogue Number: A42011A
• Device Lot Number: 095W-0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2009
• 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: A22005A.