MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM; ACCESSORIES, ARTHROSCOPIC

Catalog Number CAT02438

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the cannula cracked during the procedure.

Event Description

It was reported that the cannula cracked during the procedure.

Manufacturer Narrative

Alleged failure: the rep emailed to c360 on 5-21-2019 but it never was seen due to a glitch in our system, angel garza is aware of the issue.Seam where polymer tip meets metal shaft of flowport cannula broke.Caused obturator to become stuck and unable to be removed.Surgeon says this is second time this has occurred at same spot when using flowport.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be excessive force applied on device.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: FLOWPORT II CANNULA WITH OBTURATOR STRYKER 165MM
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8716921
• MDR Text Key: 148794569
• Report Number: 0002936485-2019-00251
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613252633181
• UDI-Public: 07613252633181
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAT02438
• Device Lot Number: 003741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1