MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, LONG, FOR WA22018A AND WA22019A; RESECTOSCOPE SHEATH

Model Number WA22017A

Device Problem Fracture (1260)

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

Event Date 02/03/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record was not performed as serial number was not provided.Manufacturing and quality control review was performed for the last 24 months of production and there are no non-conformities or deviations regarding the described issue.Based on the results of the investigation, it can 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.Also note that the cause of the reported issue is attributed to wear and tear.A definitive root cause for thermo-mechanical stress could not be identified.Unfortunately, it cannot be determined with certainty, whether there was a previous damage on the device or any damage on the ceramic insulating insert was caused during last reprocessing or during last usage.The instructions for use state: "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.

Event Description

The customer reported to olympus the ceramic tip of the inner sheath broke off while in the patient.The broken piece was recovered and case was completed with a second device.There was no harm or user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information received from the customer (b5).

Event Description

Customer confirmed it was a therapeutic cysto stent procedure.There was a minimal delay as they successfully removed the broken pieces and proceeded with the case.Customer also stated the doctor didn¿t even dictate it.The device was inspected prior to use and unable to provide the lot number of the device.

• Brand Name: INNER SHEATH, LONG, FOR WA22018A AND WA22019A
• Type of Device: RESECTOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 13749333
• MDR Text Key: 287897610
• Report Number: 9610773-2022-00094
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761051514
• UDI-Public: 04042761051514
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22017A
• Device Catalogue Number: WA22017A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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