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

Catalog Number 0450000000

Device Problem Insufficient Information (3190)

Patient Problem Extravasation (1842)

Event Date 01/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was extravasation during the procedure.

Event Description

It was reported that there was extravasation during the procedure.

Manufacturer Narrative

Alleged failure: details: preset pump pressure set to 25.Midway through the repair, the surgical team had to switch the crossflow out for another crossflow from another room because of excessive swelling.This is the second complaint, for excessive swelling, in the past 90 days from dr.(b)(6) filed in 4th quarter 2018.Pump software updated to current (b)(6) 2018.Dr.(b)(6) is considered one of the godfathers of arthroscopic shoulder surgery.This is not user error, improper set up or high pump pressure.Scoi uses day use tubing cassettes in combination with patient use tubing.Salesforce case number (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) pressure sensor malfunction, 2) main board malfunction, or 3) software error.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG, CROSSFLOW CONSOLE
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8306780
• MDR Text Key: 135055833
• Report Number: 0002936485-2019-00051
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327058048
• UDI-Public: 07613327058048
• Combination Product (y/n): N
• PMA/PMN Number: K123441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

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 Catalogue Number: 0450000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other