MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. INFLOW/OUTFLOW CANNULA; ACCESSORIES,ARTHROSCOPIC

Model Number	0747031650
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that debris remained inside the patient.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: noticed ¿fuzzy¿ quality to screen image, not specific to any one case.Then they identified the actual bioburden issue when it was sent out to 3rd-party repair the probable root cause/s could be third party repair and/or improper sterilization methods.
Event or Problem Description
It was reported that debris remained inside the patient.

• Brand Name: PKG. INFLOW/OUTFLOW CANNULA
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10076895
• Report Number: 0002936485-2020-00202
• Device Sequence Number: 16852971
• Product Code: NBH
• UDI-Device Identifier: 07613327054613
• UDI-Public: 07613327054613
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/01/2020

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 Model Number: 0747031650
• Device Catalogue Number: 0747031650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 09/01/2020
• 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