FDA Adverse Event Injury Summary report: N

CONMED BEND-A-BEAM ABC HANDPIECE

MDR report key: 404856 · Received July 16, 2002

Report

Report Number
1720159-2002-00098
Event Type
Injury
Date Received
July 16, 2002
Date of Event
June 3, 2002
Report Date
July 9, 2002
Manufacturer
CONMED ELECTROSURGERY
Product Code
GEI
Removal / Correction Number
NA
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
IT
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE PT CAME IN THE HOSPITAL WITH A DIAGNOSIS OF SPONTANEOUS LEFT PNEUMOTHORAX. A COMPUTERIZED ATRIAL TOMOGRAPHY OF THE CHEST EXCLUDED THE PRESENCE OF AIR MACRO BUBBLES. ALL TESTS AND ECG WERE NEGATIVE THUS ENABLING TO SUBMIT THE PT TO SURGERY. ON THE 4TH DAY AFTER ADMISSION DUE TO THE INCREASE OF THE PNXSX (LEFT PNEUMOTHORAX) THE PT UNDERWENT MINIMAL PLEUROTOMY WITH LEFT CHEST DRAIN. THE LOSS OF AIR THROUGHOUT THE DRAIN CONTINUED ON A CONSTANT EVEN IF MINIMAL BASIS UNTIL THE ELEVENTH DAY AFTER ADMISSION, WHEN THE PT UNDERWENT THE MINIMAL INVASIVE SURGERY. THE SURGICAL EXPLORATION OF LEFT LUNG EVIDENCED THE PRESENCE OF A SMALL APICAL BUBBLE OPENED TOWARDS THE PLEURAL CAVITY. THE SURGICAL STAFF PROCEEDED WITH RESECTION OF THE LEFT LUNG APEX THROUGH ENDO-GLA (4.8) REINFORCED WITH GORETEX AND PLEURODESIS AT THE LEVEL OF THE FIRST 3 RIBS WITH ARGON BEAM COAGULATOR. THE POST OPERATIVE COURSE WAS NORMAL, BUT AFTER TWO MORE THORAX X-RAY TESTS, A FOREIGN BODY (NEEDLE SHAPE 2CM LONG) WAS FOUND, ORIENTED TOWARDS THE LEFT HEMOTHORAX. IN THE SECOND POST-OPERATIVE DAY A CHEST X-RAY, BIDIRECTIONAL, WAS PERFORMED AND THE PRESENCE OF A FOREIGN BODY WAS CONFIRMED INSIDE THE PT'S CHEST. A THORACOSCOPY WAS PERFORMED AND THE FOREIGN BODY WAS REMOVED. THE FOREIGN BODY WAS IDENTIFIED TO BE THE NEEDLE OF THE DISPOSABLE MALLEABLE HANDSWITCH USED TO PERFORM THE 1ST PROCEDURE FOR THE APICAL PLEURODESIS. THE HANDSWITCH IS MANUFACTURED BY CONMED CORPORATION (CODE 134009, LOT 010131, EXPIRE DATE 01/2006) AND IT IS A KIND OF MALLEABLE HANDSWITCH (22, 2CM) TO BE USED IN LAPAROSCOPY AND THORACOSCOPY. SUCH HANDSWITCH IS USEFUL BECAUSE YOU CAN BEND IT, SO AS TO REACH AREAS (IN THE PLEURAL CAVITY) OTHERWISE NOT REACHABLE WITH A STRAIGHT HANDSWITCH, EVEN IF OF THE SAME LENGTH. HAVING BENT THE HANDSWITCH, AS PER THE MFR'S INSTRUCTIONS, THE SURGICAL STAFF MIGHT PROBABLY HAVE DETERMINED THE INTERNAL NEEDLE SHAPE ELECTRODE RUPTURE, WHICH THEN SLIDED OUT FROM THE HANDSWITCH PROBABLY ALSO PUSHED BY THE ARGON FLOW. THIS EVENT OCCURRED AT A TIME DURING WHICH THE HANDSWITCH WAS OUT OF THE CAMERA VISUAL FIELD. IN FACT, DURING THE PROCEDURE IT BECAME NECESSARY TO USE A SECOND HANDSWITCH BECAUSE THE FIRST ONE WAS OUT OF ORDER. THE POST-OPERATIVE FOLLOW-UP WAS REGULAR. THE SURGICAL STAFF IS WAITING FOR THE RESULT OF THE HISTOLOGICAL TESTS OF THE LEFT LUNG APEX REMOVED. THE CHEST X-RAY PRIOR TO THE PT'S DISMISSAL SHOWED THE LEFT LUNG AT SITE. THE PT WAS DISMISSED WITH CUTANEOUS STITCHES AT SITE. THE PT WAS REVIEWED AND TREATED NINE DAYS LATER AT THE OUT-PATIENT'S DEPARTMENT; THE TROCAR WOUNDS WERE O.K. AND STITCHES WERE REMOVED. AS USUAL, THE PT HAS BEEN REQUESTED TO PERFORM A CONTROL X-RAY OF THE CHEST 20 DAYS AFTER DISMISSAL (THE TEST HAS BEEN BOOKED FOR JULY. THE CASE OCCURRED LEADS TO THE FOLLOWING CONSIDERATIONS: A HANDSWITCH SPECIFICALLY DESIGNED FOR LAPAROSCOPY AND THORACOSCOPY WAS USED. THE RUPTURE OF THE INTERNAL ELECTRODE, WHICH IS NORMALLY NOT VISIBLE AND WHICH THEN FELL INSIDE THE PLEURAL CAVITY PROBABLY PUSHED BY THE ARGON BEAM COULD HAVE BEEN VERY DANGEROUS. IN FACT, THE LIMITED VIEW NORMALLY ALLOWED BY A VIDEOTHORACOSCOPY, DID NOT PERMIT STAFF TO FIND THE FOREIGN BODY UNTIL LATER DURING A MORE IN-DEPTH AND SPECIFIC SEARCH. BEING THE PT AT LOW SURGICAL RISK, THE CONSEQUENCES OF THESE EVENTS RESULTED IN A SECOND SURGICAL PROCEDURE WITH A 2-DAY LONGER STAY IN THE HOSPITAL. THIS REPORT IS PRODUCED DUE TO POSSIBLE LEGAL SUIT BY THE PT. THE SURGICAL STAFF IS AT YOUR DISPOSAL FOR ANY FURTHER TECHANICAL CLARIFICATION YOU MAY NEED AND TO INFORM YOU ABOUT THE PT'S FOLLOW-UP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CONMED BEND-A-BEAM ABC HANDPIECE ABC HANDPIECE GEI CONMED ELECTROSURGERY BEND-A-BEAM HANDPIECE 010131

Patients

Seq Age Sex Outcome Treatment
1 17 YR Other| R