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

Catalog Number	CAT00778
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported there was increased traction time.
Event or Problem Description
It was reported there was increased traction time.
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: 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
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10276362
• Report Number: 0002936485-2020-00276
• Device Sequence Number: 11529309
• Product Code: NBH
• UDI-Device Identifier: 07613252632917
• UDI-Public: 07613252632917
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1