MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CROSSFLOW INTEGRATED ARTHROSCOPY PUMP - INTERNATIONAL KIT; ARTHROSCOPE

Catalog Number 0450000000I

Device Problem Pressure Problem (3012)

Patient Problem Swelling (2091)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was pressure issue with the pump which caused the patient's shoulder to swell.The procedure was completed successfully.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: pressure displayed different to that in the patient confirmed failure: e3, e4, e11-e14, software upgrade needed.Probable root cause: pressure sensor malfunction/out of calibration software malfunction the reported failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported that there was pressure issue with the pump which caused the patient's shoulder to swell.The procedure was completed successfully.

• Brand Name: CROSSFLOW INTEGRATED ARTHROSCOPY PUMP - INTERNATIONAL KIT
• 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: victoria milich ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6200182
• MDR Text Key: 63499094
• Report Number: 0002936485-2016-01211
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K123441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0450000000I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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