FDA Adverse Event Injury Summary report: N

INCISOR, 4.5, DISP, BLADE , EP-1

MDR report key: 4782129 · Received May 19, 2015

Report

Report Number: 1219602-2015-00105
Event Type: Injury
Date Received: May 19, 2015
Date of Event: April 14, 2015
Report Date: April 21, 2015
Manufacturer: SMITH & NEPHEW, INC.
Product Code: HAB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

LOT NUMBER WAS REQUESTED FROM FACILITY BUT A RESPONSE HAS NOT BEEN RECEIVED. \ DEVICE WAS REQUESTED FOR EVALUATION, BUT HAS NOT BEEN RETURNED. CURRENT LOCATION OF DEVICE IS STILL IN POSSESSION OF THE FACILITY. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

CUSTOMER REPORTED WHILE SURGEON WAS MAKING THE INCISION AND VERTEBRAL PUNCTURE, THE PATIENT¿S LEG SHOOK AFTER INSERTING SMITH & NEPHEW BLADE. SURGEON THOUGHT IT WAS DUE TO INSUFFICIENT ANESTHESIA, SO THE ANESTHESIA WAS STRENGTHEN TO PROCEED WITH PROCEDURE. A SKIN BURN WAS FOUND ON PATIENT OFFSIDE THE BLADE, AFTER PROCEDURE. THE BLADE WAS TAKEN OUT TO FIND BURNT LIKE AREA ON ITS FRONT. THE ENGINEER PERFORMED A TEST TO SIMULATE ACTUAL OPERATION CONDITION AND NO ELECTRIC LEAKAGE WAS FOUND. PATIENT¿S BURN WAS CLEANED AND BANDAGED, HOWEVER THE NEXT DAY FOUND THE WOUND TO BE MORE SERIOUS THAN EXPECTED. PATIENT UNDERWENT SKIN GRAFT SURGERY ON THE (B)(6). (REFERENCE: (B)(4) FOR HAND CONTROL UNIT USED WITH THE BLADE).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
326939	INCISOR, 4.5, DISP, BLADE , EP-1	SAW, POWERED, AND ACCESSORIES	HAB	SMITH & NEPHEW, INC.	UNKNOWN	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Hospitalization\| O\| R