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 Date 05/07/2020

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 mail that states, in (b)(6) 2020, during a transurethral resection of a bladder tumor procedure, the ceramic tip at the distal end of the resectoscope inner sheath broke off and fell into the patient's bladder.The doctor used a grasper to retrieve the broken piece without issue.There was no patient injury reported.The customer noted the approximate age of device was one day.

Manufacturer Narrative

This supplemental report was submitted to provide new information for mdr.The risk management coordinator at the user facility reported there was no delay in the procedure.There was no patient injury / harm noted.The entire ceramic tip was retrieved by the surgeon.The current condition of the patient was no harm noted.The lot number provided was invalid.The event date (b3) was updated.The investigation is ongoing, however, if additional information becomes available this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr.The oem could not performed a device history record review as the serial number remains invalid/unknown.Instead, the manufacturing and quality control review was performed for the last 24 months of production without showing any non-conformities or deviations regarding the described issue.Based on the investigation results, the potential cause for the reported issue is very likely thermo-mechanical fatigue / wear and tear.Please note that signs of fatigue or pre-damage, such as minute cracks, are often hard to spot.It cannot be determined whether the damage was triggered in the course of the procedure or during reprocessing.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: 10473355
• MDR Text Key: 231685285
• Report Number: 9610773-2020-00201
• 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,Followup
• Report Date: 12/16/2020

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: 09/09/2020; 11/17/2020
• Supplement Dates FDA Received: 09/10/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR