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

Model Number A22040A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, multiple follow-ups to the user facility were made in an attempt to gather additional information on the reported event; however, no additional information was obtained.A review of the device history records (dhr) was conducted for the concerned lot and indicated there were no deviations or non-conformities regarding the described issue.The device was manufactured in october 2018.The referenced sheath was not returned to the service center for evaluation, the cause of the reported event cannot be determined at this time, however, if additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.To mitigate the risk of device damage or patient injury, the instruction manual states to, "visually inspect the product and make sure that it has no corrosion, no dents and no scratches.Inspect the ceramic insulation at the sheath's distal end before each use.Do not use the instrument in case of damage ( cracks, fractures).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.".

Event Description

The manufacturer was informed that during a procedure, some ceramic type bits from the sheath fell into the patient.The device fragments were retrieved.There was no patient injury reported.

• Brand Name: INNER SHEATH, FOR 26 FR. OUTER SHEATH
• Type of Device: INNER SHEATH, FOR 26 FR
• 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: 9263317
• MDR Text Key: 196292309
• Report Number: 9610773-2019-00151
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761029339
• UDI-Public: 04042761029339
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2019

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: 18XW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/31/2019
• 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: Initial
• Patient Sequence Number: 1