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

Catalog Number	CAT00776
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the procedure was converted to an open procedure.
Event or Problem Description
It was reported that the procedure was converted to an open procedure.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: broken flowport cannula.Probable root cause: design: inadequate raw material selection, poor assembly design, inadequate packaging design, manufacturing: incorrect raw materials used during processing, device incorrectly assembed, application: inappropriate handling of device during previous use/reprocessing.The reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

• Brand Name: FLOWPORT II CANNULA WITH OBTURATOR
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8471349
• Report Number: 0002936485-2019-00125
• Device Sequence Number: 1633709
• Product Code: NBH
• UDI-Device Identifier: 07613252632887
• UDI-Public: 07613252632887
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CAT00776
• Device Lot Number: 003654
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other