MAUDE Adverse Event Report: MICROLINE SURGICAL, INC. UNIVERSAL POWER SUPPLY; AC POWERED THERMAL CAUTERY UNIT

Model Number 200-006R

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

Not applicable.

Event Description

During the surgical procedure, the universal power supply sound indicator stopped working.The surgical procedure time was extended for forty five (45) minutes.There was no harm to the patient.

• Brand Name: UNIVERSAL POWER SUPPLY
• Type of Device: AC POWERED THERMAL CAUTERY UNIT
• Manufacturer (Section D): MICROLINE SURGICAL, INC. ; beverly MA
• Manufacturer Contact: anu gaur ; 50 dunham road; ste 1500; beverly, MA 01915 ; 9788671726
• MDR Report Key: 5187891
• MDR Text Key: 29946645
• Report Number: 1223422-2015-00042
• Device Sequence Number: 1
• Product Code: HQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 200-006R
• Device Catalogue Number: 200-006R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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
• Patient Outcome(s): Other