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

Model Number A22041A

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

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

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation found the reported issue was confirmed.Evaluation noted "tip fell off" due to broken beak.Passage and locking inspection noted no issues.Device history record (dhr) review noted that a manufacturing and quality control review was performed for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported the device "tip fell off".The issue found during reprocessing.There was no patient involvement on this reported event.No harm was reported, no user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the inspection results were evaluated as plausible.According to the event description, the tip of the sheath was broken off.During inspection, the phenomenon was reproduced.It was surmised that the reported damage was most probably induced by thermo-mechanical fatigue.It cannot be determined whether there was advanced wear and tear or pre-existing damage.Furthermore, it cannot be determined whether the final damage was triggered in the course of the procedure or during reprocessing.It was recommended to perform an exploratory x-ray or computed tomography in case there are doubts whether fragments of the insulating insert remained inside the patient, before using the product, the warning notices in the ifu should be followed to ensure a faultless condition of the product.See especially chapter 4: ¿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.¿ a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Olympus will continue to monitor field performance for this device.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: ENDOSCOPE SHEATH, REUSABLE
• 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: 16897701
• MDR Text Key: 314860213
• Report Number: 9610773-2023-01262
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• 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: Health Professional
• Device Model Number: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: 15XW-0066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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