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

Model Number 0450000000

Device Problem Pressure Problem (3012)

Patient Problems Extravasation (1842); No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported there was an incorrect pressure reading that led to overpressure.

Manufacturer Narrative

Alleged failure: cib matthew sparrow, rep, the pressure readings are all off, the patience joint became bloated due to absorption of the saline fluid not being pupped out fast enough.Salesforce case number (b)(4) the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be pressure senor malfunction, main board malfunction, old revision sensor bracket.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported there was an incorrect pressure reading that led to overpressure.

• 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: 9461702
• MDR Text Key: 170664034
• Report Number: 0002936485-2019-00554
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0450000000
• Device Catalogue Number: 0450000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other