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

Model Number CAT01549

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tip of the device broke during the procedure.The tip was retrieved.

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: tip break.Probable root cause: design: inadequate material selection to support movement/manipulation by user cannula tubing thickness too small to support movement/manipulation by user cannula size or geometry does not promote proper visualization of joint excessively sharp tip of cannula damages tissue manufacturing cannula not assembled, molded or machined to specification application excessive force poor visualization through arthroscope.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text: 81.

Event Description

It was reported that the tip of the device broke during the procedure.The tip was retrieved.

• Brand Name: FLOWPORT II CANNULA WITH OBTURATOR, LINVATEC & STORZ
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11499059
• MDR Text Key: 242082870
• Report Number: 0002936485-2021-00155
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613252633051
• UDI-Public: 07613252633051
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CAT01549
• Device Catalogue Number: CAT01549
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1