MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, FLOSTEADY - ARTHROSCOPY POLE PUMP; RASP, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 0350800001

Device Problem Smoking (1585)

Patient Problem No Information (3190)

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).

Event Description

It was reported that smoke was coming from the pump.

Manufacturer Narrative

Alleged failure: smoking mid case.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause for the smoke could be burned components from a short due to dropping damage.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Gtin:(b)(4).

Event Description

It was reported that smoke was coming from the pump.

• Brand Name: PKG, FLOSTEADY - ARTHROSCOPY POLE PUMP
• Type of Device: RASP, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 6134002
• MDR Text Key: 61343689
• Report Number: 0002936485-2016-01124
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062380
• 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: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0350800001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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