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

Model Number A22040A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As part of the investigation, olympus followed up with the customer to obtain additional information regarding the reported event but no information has been obtained.Additionally, no device has been returned for evaluation.However, the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

On august 5, 2020, olympus received a medwatch report (b)(4) via that states, in (b)(6) 2019, the tip of the inner cystoscopy sheath broke during use.The surgeon found a piece of the tip in the patient's bladder.The broken piece was removed and it was reported the entire single piece matched the broken tip of the sheath.There was no harm to the patient.The damaged sheath was separated from the tray and sent to sterile processing department (spd) for replacement.The approximate age of device was 15 years old.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer (oste) for mdr# 9610773-2020-00200.As part of the investigation, olympus followed up with the user facility to obtain additional information but with no results the legal manufacturer was unable to perform a review of the device history records as the lot number is unknown.The investigation was completed by the legal manufacturer determined that the reported damage was most probably induced by thermo-mechanical fatigue.It cannot be determined whether there was 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.The item doesn¿t comply with the product specification and can no longer be used.The most probable cause for the reported issue is very likely wear and tear.Olympus will continue to monitor complaints for this device.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: INNER SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 10473352
• MDR Text Key: 231686061
• Report Number: 9610773-2020-00200
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• Combination Product (y/n): N
• PMA/PMN Number: K931995
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

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: A22040A
• Device Catalogue Number: A22040A
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR