MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; HYSTEROSCOPE (AND ACCESSORIES)

Model Number A22041A

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported the resection sheath exhibited the insulating part was broken (broken ceramic tip).There were no reports of patient harm.

Manufacturer Narrative

The device evaluation found; the ceramic tip of the tube was broken.Based on the results of the investigation, it is likely that the following led to the malfunction: thermo-mechanical fatigue.Wear and tear.Improper handling (impact, shock).As a general note, cracks on the insulation material are mostly not visible, making visual inspection difficult.Worn o-rings: the cause is very likely wear and tear.A device history review revealed no issues that could have caused or contributed to the reported issue.This issue is addressed in the instructions for use (ifu): "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: 1.No corrosion.2.No dents.3.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).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 the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19041756
• MDR Text Key: 340109602
• Report Number: 9610773-2024-00955
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• 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: 17ZW-0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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