FDA Adverse Event Malfunction Summary report: N

ENDOSTITCH SURGIDAC

MDR report key: 3141789 · Received May 22, 2013

Report

Report Number
3141789
Event Type
Malfunction
Date Received
May 22, 2013
Date of Event
May 10, 2013
Report Date
May 22, 2013
Manufacturer
COVIDIEN, FORMERLY US SURGICAL
Product Code
KOG
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

DURING SURGERY, DOCTOR ASKED FOR A ENDOSTITCH WITH SURGIDAC SUTURE. TECH NOTED THAT THE NEEDLE WAS BROKEN WHEN DOCTOR PASSED BACK THE ENDOSTITCH. THE NEEDLE IS HALF-MISSING. DOCTOR MADE AWARE. X-RAY WAS TAKEN AND RADIOLOGIST READ THE RESULT.AN X-RAY WAS TAKEN AND THE NEEDLE LOCATED, HOWEVER, IT WAS UP IN THE CHEST AREA AND WOULD REQUIRE AN OPEN PROCEDURE TO RETRIEVE. THE SURGEON DETERMINED THAT IT WAS NOT IN THE PATIENT'S BEST INTEREST TO PERFORM SUCH A PROCEDURE TO RETRIEVE, AS THE NEEDLE ITSELF WOULD NOT CAUSE HARM. SO, THE MEDICAL DECISION WAS TO LEAVE IN THE NEEDLE. THIS WAS DONE WHILE STILL IN THE OR AND ACCORDING TO OUR POLICIES.PATIENT WAS INFORMAED AND DISCHARGED WITHOUT FURTHER ISSUE. HE WILL BE FOLLOWED BY MD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC CHOLECYSTECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
226567 ENDOSTITCH SURGIDAC DEVICE, SUTURING, ENDOSCOPIC KOG COVIDIEN, FORMERLY US SURGICAL * J2HOO56X

Patients

Seq Age Sex Outcome Treatment
1 53 YR ENDO STITCH AUTO SUTURE (SUTURING DEVICE)| REF: 173016, LOT: N2GOO24X, EXP: 07/31/2017