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

Catalog Number CAT00778

Device Problems Fluid/Blood Leak (1250); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

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.

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.The device manufacturer date is not known.The investigation was previously closed based on product not received; however, the product has now been physically received at stryker endoscopy, usa and the investigation has been re-opened.Investigation as follows is now based on product received.Alleged failure: as reported: "both adapters in birmingham team¿s inventory are missing internal suction ring causing the flowport adapter to leak and spray water all over surgeon".The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) inappropriate disassembly of device during reprocessing, 2) rough handling of device during reprocessing, or 3) excessive force applied on device.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: 10276362
• MDR Text Key: 199515632
• Report Number: 0002936485-2020-00276
• 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: 10/01/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• 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: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1