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

Model Number A22041A

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Event Description

The customer reported that the cap of the sheath was detached.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: scraping on the inside of the tip of the beak.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The subject device was returned to an olympus repair center for evaluation and the customer¿s reported issue was confirmed, the cap was detached.The device evaluation found scraping on the inside of the tip of the beak.It was also found that the rubber seal was discolored and there was damage on the tension ring.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Three attempts were performed to obtain additional information, but no response was received from the customer.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 15 years since the subject device was manufactured.Based on the results of the investigation, root cause of the reported damage is consistent with wear from use over time and improper handling.However, specific root cause could not be determined.The issue can be detected/prevented by following the instructions provided in: the instructions for use, chapter 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.Olympus will continue to monitor field performance for this device.

• Brand Name: RESECTION SHEATH, 24 FR.
• 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: 18023241
• MDR Text Key: 326753181
• Report Number: 9610773-2023-03099
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• 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: 08XW-0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• 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