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

Model Number A22041A

Device Problem Break (1069)

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

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

Additional details regarding the reported event was requested from the customer and is pending.The lot number could not be determined, a dhr review could therefore not be performed.No device has been returned to date so the root cause of the reported event cannot be determined.Based on the legal manufacturer¿s investigation, it is assumed that the damage of the insulation material of the sheath was caused by thermal mechanical overload, improper handling, mechanical impact like fall, shock or similar stress.The cause of the reported issues is attributed to wear and tear.Signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.To mitigate the risk of device damage and patient injury, the instructions for use (ifu) provides the following: 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.Inspecting the product: visually inspect the product.Make sure that it has: no corrosion, no dents and no scratches.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).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.Additionally, in the case of unclear remains of fracture fragments, of the insulating insert made of ceramic, these can be localized with a suitable x-ray procedure or computer tomography and removed, if necessary.

Event Description

The olympus sales representative became aware that the resection sheath¿s ceramic tip broke off inside the patient¿s bladder.The customer was able to retrieve the broken tip from the patient and put it into a contamination bag.No death or injury was reported to olympus.

Manufacturer Narrative

This supplemental report was submitted to provide the device evaluation results.The subject device was returned to olympus for evaluation.The reported issue was confirmed, the ceramic insulation at the distal tip of the sheath was found broken off and the piece(s) was not returned.A portion of the ceramic insulation was observed inside the sheath damaged with sharp jagged edges.Also, minor scratches and dents on the sheath were noted.As part of the investigation, olympus followed up with the sales rep to obtain additional information regarding the reported event, but no information has been obtained to date.However, the investigation is still in progress.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report was submitted to provide the device evaluation results.The subject device was returned to olympus for evaluation.The reported issue was confirmed, the ceramic insulation at the distal tip of the sheath was found broken off and the piece(s) was not returned.A portion of the ceramic insulation was observed inside the sheath damaged with sharp jagged edges.Also, minor scratches and dents on the sheath were noted.As part of the investigation, olympus followed up with the sales rep to obtain additional information regarding the reported event, but no information has been obtained to date.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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, de 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: 15934148
• MDR Text Key: 308403537
• Report Number: 9610773-2022-00600
• 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: K931994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• 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: 21401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2021
• 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