MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FG, FLOWPORT II ADAPTER, STRYKER; ACCESSORIES, ARTHROSCOPIC

Catalog Number CAT00778

Device Problems Leak/Splash (1354); Appropriate Term/Code Not Available (3191)

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

Event Date 06/15/2020

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 there was increased traction time.

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: leaking adaptor.Probable root cause: design: poor interconnection design.Manufacturing: adapter or cannula not manufactured to specification.Application: user error - cannula/adapter not connected properly.Improper handling causes damage to cannula/adapter.The reported failure mode will be monitored for future reoccurrence.Manufacturing date is not known.H3 other text : 81.

Event Description

It was reported there was increased traction time.

• Brand Name: FG, FLOWPORT II ADAPTER, STRYKER
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10276357
• MDR Text Key: 199515550
• Report Number: 0002936485-2020-00275
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613252632917
• UDI-Public: 07613252632917
• 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: 09/09/2020

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 Catalogue Number: CAT00778
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1