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

Model Number A22040A

Device Problem Crack (1135)

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

Event Date 05/18/2023

Event Type  malfunction  

Event Description

The customer reported that the ceramic insulation at the distal tip of the inner resectoscope sheath was found to have a crack during reprocessing.The device was replaced, and the scheduled transurethral resection of the bladder tumor procedure was completed.There was a delay in replacing the equipment, but the amount of time is unknown.No death or injury and no impact to patient or other was reported.The device was inspected prior to use but no anomalies were noted.

Manufacturer Narrative

The referenced device was returned for evaluation and the inspection confirmed the customer¿s reported issue.A large portion of the ceramic insulation at the distal tip of the device was broken off.No further information regarding the event was provided by the customer.A review of the (dhr) manufacturing and quality records for the affected lot number was reviewed without detecting any non-conformities or deviations regarding the described issue.The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.Additional 510(k): k931994.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).Based on the results of the investigation, the root cause could not be determined.It is likely the damage to the tip was caused by one of the following; a thermal/mechanically induced impact, wear and tear, improper handling, and/or a mechanical overload (such as impact from a fall, shock, or similar stress).It was further noted that it cannot be determined with certainty, whether there was pre-existing damage or if it had occurred during the last procedure or last reprocessing.The instructions for use (ifu) provides a warning that the ceramic tip can break due to mechanical loading or thermally induced straining: ¿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 field performance for this device.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: RESECTOSCOPE 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: 17137598
• MDR Text Key: 318081102
• Report Number: 9610773-2023-01656
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: 22412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• 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
• Treatment: OLYMPUS: WA22367A, WORKING ELEMENT.