MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, CROSSFLOW CONSOLE; ARTHROSCOPE

Catalog Number 0450000000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the joint was distending.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed.Alleged failure: distendening the joint.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: user setup.Improper joint level.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the joint was distending.

• Brand Name: PKG, CROSSFLOW CONSOLE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7545549
• MDR Text Key: 109296682
• Report Number: 0002936485-2018-00461
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327058048
• UDI-Public: 07613327058048
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0450000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other