FDA Adverse Event Injury Summary report: N

OPMI PENTERO

MDR report key: 1417983 · Received May 21, 2009

Report

Report Number
1417983
Event Type
Injury
Date Received
May 21, 2009
Date of Event
March 24, 2009
Report Date
May 21, 2009
Manufacturer
CARL ZEISS, INC.
Product Code
EPT
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
CT, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

DURING A SURGICAL PROCEDURE (THORACIC LAMINECTOMY FOR SYRINX) A SUSPECTED BURN DEVELOPED AT THE INCISION SITE, AND AFTER INVESTIGATION AND RESEARCH, IT IS POSSIBLE THE REACTION MAY BE DUE TO A COMBINATION OF THE HEAT FROM THE MICROSCOPE'S XENON LIGHT SOURCE, THE USE OF DURAPREP AND THE IOBAN ANTIMICROBIAL DRAPE.THERE WAS NO IGNITION OR CHARRING OF THE DRAPE. THE NURSE CIRCULATING IN THIS CASE STATES THAT AT THE CONCLUSION OF THE CASE, UPON REMOVAL OF THE IOBAN DRAPE, IT APPEARED THAT THE SKIN LOOKED SOMEWHAT RED, AND THE IOBAN DRAPE WAS DIFFICULT TO REMOVE. THERE WAS SOME DISCUSSION BETWEEN THE SURGEON, THE PA, AND THE NURSE RELATED TO THE INTEGRITY OF THE SKIN AND WHETHER OR NOT IT WARRANTED MORE ATTENTION AT THAT TIME, BUT ACCORDING TO THE NURSE IN THE ROOM IT WAS DETERMINED THAT THERE WAS NO SERIOUS DAMAGE THAT THEY OBSERVED AT THE TIME. A DRY, STERILE DRESSING WAS APPLIED AND THE PATIENT HAD A TWO DAY STAY.THE MICROSCOPE USE IN THE CASE WAS LESS THAN 30 MINUTES. THERE WAS NO CHARRING, FIRE OR DRAPE IGNITION. THE LIGHT OF THE MICROSCOPE WAS 50% AND THE CIRCLE WAS RESTRICTED TO THE INTRADURAL AREA OF MICROSURGERY. IT IS NOT CLEAR THAT THE SKIN LESIONS ARE LIGHT RELATED BURNS. EQUALLY POSSIBLE IS A CHEMICAL BURN FROM THE DURA-PREP.HEALING IS PROGRESSING QUITE WELL. THERE HAVE BEEN NO ADDITIONAL SURGERIES REQUIRED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 OPMI PENTERO MICROSCOPE, SURGICAL EPT CARL ZEISS, INC. OPMI PANTERO *
2 IOBAN DRAPE, SURGICAL KKX 3 M HEALTH CARE * *
3 DURAPREP SURGICAL PREP SOLUTION KOY 3M HEALTH CARE * *

Patients

Seq Age Sex Outcome Treatment
1 9 YR Required Intervention OTHER| OTHER