inforMED
InjuryFSZ

MAST QUADRANT RETRACTOR SYSTEM

Received Aug 11, 2015 · Event occurred Jun 30, 2015

Report MW5055393 · MDR key 5006639

Device

Generic name

Mast Quadrant Retractor System

Manufacturer

Medtronic

Model number

00 MLX

Catalog number

401327T

Lot number

0362288W

Product problems

  • Insufficient Device Problem Information

Patient

51 YR

  • Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

PT IS A (B)(6) MALE WITH THE LOW BACK PAIN AND BILATERAL EXTREMITY PAIN AND NUMBNESS. PT HAD BEEN EXPERIENCING PROGRESSIVELY WORSENING SYMPTOMS DESPITE NON-OPERATIVE MANAGEMENT. PT CONSENTED TO SURGICAL TREATMENT. PT STATUS POST LEFT L3-4 DIRECT LATERAL INTERBODY FUSION WITH POSTERIOR INSTRUMENTATION ON (B)(6) 2015; AFTER SURGERY, WHEN DRAPES WERE REMOVED, THE PT WAS FOUND TO HAVE A LEFT FLANK "BURN" OF 7 X 2.5 CM NON-BLANCHABLE ERYTHEMA WITH A FLUID FILLED BLISTER IN THE CENTER MEASURING 3.5CM X 1.5 CM. THERE WAS NO EVIDENCE OF ANY ALTERATION TO THE STERILE DRAPES (I. E. - BURN MARK). THIS DISCOVERED EVENT WAS DISCUSSED / EXAMINED BY THE SURGICAL TEAM, ANESTHETIC TEAM AND THE CIRCULATING NURSE. THE SURGICAL TEAM DISCUSSED THE POSSIBILITY OF THE BURN OCCURRING FROM THE LIGHT CORD CONNECTION TO THE FIBEROPTIC CABLE AND ALL COMPONENTS WERE COLLECTED/DELIVERED TO THE OPERATING ROOM MANAGER FOR FULL INVESTIGATION BY THE CLINICAL ENGINEERING DEPARTMENT. THE BURN AREA WAS COVERED WITH A STERILE DRESSING AND A WOUND CARE SPECIALIST WAS CONSULTED. POSTOPERATIVELY THE LEFT FLANK WOUND WAS CLEAN AND HEALING APPROPRIATELY. PT WAS FOLLOWED CLOSELY BY THE WOUND CONSULT SERVICE. THE SPINE SERVICE CHECKED WOUND AT DISCHARGE AND PT WAS TO F/U IN TWO WEEKS. PT'S SPINE SURGEON SPOKE TO DERMATOLOGIST AND ORDERED SILVER SULFADIAZINE 1% CREAM APPLICATION WITH TAPE TWICE DAILY AND INSTRUCTED TO COVER WITH DRESSING. PT DISCHARGED HOME WITH HOME (B)(6) SERVICES FOR DRESSING CHANGES AND WOUND MONITORING. UPON F/U VISIT WITH THE SPINE SURGEON ON (B)(6) 2015, IT WAS DISCOVERED THAT THE BURN HAD INCREASED TO A SERIOUS REPORTABLE EVENT REQUIRING A CHANGE IN THE TREATMENT PLAN WITH QUESTION DEBRIDEMENT OF WOUND AND INCREASED DRESSING CHANGES. REASON FOR USE: VISUALIZATION OF DEEP INCISION WITH LIGHTED RETRACTOR.