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

Model Number 0747031650

Device Problems Contamination /Decontamination Problem (2895); Contamination of Device Ingredient or Reagent (2901)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacture 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 debris remained inside the patient.

Event Description

It was reported that debris remained inside the patient.

Manufacturer Narrative

*note: 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: 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 salesforce case number (b)(4).Additional information received states that ¿flecks of cooked bioburden came out and into the patient¿.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be third party repair and/or improper sterilization methods.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: PKG. INFLOW/OUTFLOW CANNULA
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10076876
• MDR Text Key: 191659414
• Report Number: 0002936485-2020-00201
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613327054613
• UDI-Public: 07613327054613
• 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: 08/25/2020

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
• Device Operator: 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 Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other