MAUDE Adverse Event Report: INTEGRA YORK PA, INC. INTEGRA®; LIGHT, HEADBAND, SURGICAL

Model Number 90500

Device Problems Smoking (1585); Improper or Incorrect Procedure or Method (2017); Sparking (2595)

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

Event Date 01/19/2020

Event Type  malfunction  

Event Description

An operating room patient care technician was setting up an operating room for a surgery that required use of a headlight.The integra headlight is used along with a battery pack that clips to the surgeon's waist.The patient care technician correctly identified the headlight and grabbed a cord he believed to be the connector between the headlight and battery pack as it looked the same.He brought the two components together and states there was a spark, smoke, and he dropped the two.The cord in fact belonged to a wall unit battery charger for another piece of equipment, the spider2.

• Brand Name: INTEGRA®
• Type of Device: LIGHT, HEADBAND, SURGICAL
• Manufacturer (Section D): INTEGRA YORK PA, INC.; 589 davies dr; york PA 17402
• MDR Report Key: 9641375
• MDR Text Key: 176777267
• Report Number: 9641375
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2020

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: No Information
• Device Model Number: 90500
• Device Catalogue Number: 90500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA