MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG EYEMAG LIGHT SUPPLY UNIT; LOUPE, DIAGNOSTIC/SURGICAL

Catalog Number 304121-9002-000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 09/26/2013

Event Type  Injury  

Event Description

The site reported that near the end of a surgical procedure performed using the eyemag pro light led illumination system liquid leaked from the battery pack, burned through the surgeon's pants and underwear, and contacted his skin.It was further reported that the surgeon sustained a third degree full thickness 1 x 3 cm burn on his right anterior thigh for which he did not seek medical attention.The burn left a permanent scar on his skin.

Manufacturer Narrative

A field service engineer (fse) performed an on-site inspection.It was reported that battery leakage was due to using non-rechargeable batteries.Site contact information: same as initial reporter.

• Brand Name: EYEMAG LIGHT SUPPLY UNIT
• Type of Device: LOUPE, DIAGNOSTIC/SURGICAL
• Manufacturer (Section D): CARL ZEISS MEDITEC AG; oberkochen ; GM
• Manufacturer (Section G): CARL ZEISS MEDITEC AG; carl zeiss strasse 22; oberkochen 7344 7; GM 73447
• Manufacturer Contact: judy brimacombe ; 5160 hacienda drive; dublin, CA 94568 ; 5574616
• MDR Report Key: 3687718
• MDR Text Key: 19592382
• Report Number: 9615010-2014-00007
• Device Sequence Number: 1
• Product Code: FSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 304121-9002-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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
• Patient Age: 42 YR
• Patient Weight: 88