MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; RESECTION SHEATH FOR RESECTOSCOPES

Model Number A22040A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/22/2024

Event Type  Injury  

Event Description

It was reported the tip of the resection sheath was broken off and was discovered during reprocessing.It was unknown whether the broken part was in the patient.Due to the lack of knowledge as the whether the piece had broken off in situ, a computed tomography (ct) scan and an x-ray were performed to rule this out.Additional information was requested; however, no further information was provided regarding the event or the patient.

Manufacturer Narrative

The device was not returned to olympus for evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over four years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, likely factors causing the broken ceramic tip include: a thermally mechanically induced damage/wear is assumed, possibly in connection with mechanical overload due to impact, fall or similar influence (leading to cracks in the insulation material).This issue is addressed in the instructions for use (ifu): ¿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 the field performance of this device.

Manufacturer Narrative

This report is being supplemented to provide correction to the initial with information inadvertently left out h6.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTION SHEATH FOR RESECTOSCOPES
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18793953
• MDR Text Key: 336394777
• Report Number: 9610773-2024-00557
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Lot Number: 19704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• 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
• Patient Outcome(s): Required Intervention