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 Blood Loss (2597)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed. (b)(4).

Event Description

It was reported that the console did not achieve tamponade which lead to excessive bleeding during a procedure. The procedure was completed successfully with the use of a back up device.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was not confirmed. Alleged failure: this pump did not appear to prime correctly. This caused excessive bleeding, and a lack of tamponade. The failure alleged in the complaint record was not confirmed/duplicated during the product investigation. The probable root causes could be user setup, pinched valve on cassette. The reported failure mode will be monitored for future reoccurrence. (b)(4).

Event Description

It was reported that the console did not achieve tamponade which lead to excessive bleeding during a procedure. The procedure was completed successfully with the use of a back up device.

• 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: 7509037
• MDR Text Key: 108108675
• Report Number: 0002936485-2018-00422
• Device Sequence Number: 1
• Product Code: HRX
• 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: user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 0450000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse