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

Model Number A22041A

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

This combined initial/supplemental report is being submitted to provide the initially reported event as well as the results of the manufacturer¿s investigation.A device evaluation, a review of the device history record (dhr), a review of the instructions for use (ifu), as well as a historical trending analysis were conducted during this investigation.The device was returned, during the evaluation, the user¿s report was confirmed.It was discovered that the guide screw had fallen off the unit.There was a wobble on the cap, and cracks located in the yellow/gray rubber seal.Additionally, as noted in b5, the inside of the devices tip had scratching/cutting present.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿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 (i.E.Cracks, fractures).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.If the product is damaged or does not function properly, contact an olympus representative or an authorized service center.¿ based on the results of the investigation a definitive root cause could not be determined.However, based on the condition of the subject device, it is believed that thermal and mechanical induced impact, fatigue, and/or improper handling caused the reported failure mode.Olympus will continue to monitor the field performance of this device.

Event Description

The customer originally returned his olympus 24 french resection sheath due to unspecified mechanical damage.There was no patient harm reported as a result of the above event.During the device evaluation, it was discovered that the inside of the tip was cut.This report is being submitted to capture the cut tip confirmed during the device evaluation.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17910977
• MDR Text Key: 325359363
• Report Number: 9610773-2023-02868
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22041A
• Device Lot Number: 177W-0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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