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

Model Number A22041A

Device Problems Crack (1135); Separation Problem (4043)

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

Event Date 04/03/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that during reprocessing, there was a burnt part of the 24 french resection sheath, probably from the laser.The part did not fall into the patient¿s body and stayed in the nurse¿s hand.The procedure was completed successfully without complications or prolongation.No patient harm was reported.

Manufacturer Narrative

The device was not returned for analysis as it was discarded.However, a physical inspection was performed before the device was discarded and the customers¿ allegations were confirmed; there was a damaged insulating tip at the distal end of the casing and there were small depressions in the casing of the tube.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been almost 12 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause cannot be identified.It is assumed that the reported damage is probably induced by thermo-mechanical fatigue, wear and tear, or improper handling.As a general note, cracks on the insulation material are mostly not visible, making visual inspection difficult.It cannot be determined whether there is 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.Additionally, it was identified that the sheath is dented.The cause of the dented sheath is very likely excessive force during use or reprocessing.Before using the product, the warning notices in the ifu should be followed to ensure a faultless condition of the product.See corresponding ifu warnings below: ¿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 supplemental report is being created as a correction due to additional information received as the device was evaluated onsite by an olympus field safety engineer.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: RESECTOSCOPE 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: 16899977
• MDR Text Key: 314901783
• Report Number: 9610773-2023-01271
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K931994
• 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: 05/11/2023

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: 11YW-0005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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