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 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center.The evaluation found estimation confirmed the reported ceramic tip at the distal end of the inner sheath broke off.No other defects were noted.The device was repaired to specification and returned to the customer.The investigation is ongoing; therefore, the root cause of the reported b40 error cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

During the middle of an unspecified therapeutic procedure, the ceramic tip at the distal end of the inner sheath broke off and fell inside the patient's bladder.As a result, there was a delay as the broken fragment was retrieved and the procedure was completed using a replacement sheath.Additionally, the user facility further reported no other devices were involved and no other devices were replaced during the procedure.No death or serious injury was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.More than 12 years have passed since the subject device was manufactured.Based on the results of the investigation, the event was likely caused by wear over time or physical impact.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: INNER SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11020512
• MDR Text Key: 227165539
• Report Number: 9610773-2020-00292
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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: 089W-0029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1