FORCEPS CEV405 FENESTRATED 350MM JOHANN [MXI/XOM]

Report

Report Number: 9680837-2014-00020
Event Type: Injury
Date Received: March 19, 2014
Report Date: February 20, 2014
Manufacturer: XOMED MICROFRANCE MFG
Product Code: GEI
PMA / PMN Number: K993655
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT: (1) 120MM STOP CORK TROCAR DIA 10MM (CEV112I); LOT: 130801; QUANTITY 2; MANUFACTURED: AUGUST 2013; RETURNED TO MEDTRONIC: FEBRUARY 25, 2014; 510K: K993653; PRODUCT CODE: HET (2) 80MM STOP CORK TROCAR DIA 10MM (CEV110I); LOT: 130801; QUANTITY 1; MANUFACTURED: AUGUST 2013; RETURNED TO MEDTRONIC: FEBRUARY 25, 2014; 510K: K993653; PRODUCT CODE: HET (3) 80MM STOP CORK TROCAR DIA 10MM (CEV110I); LOT: 130901; QUANTITY 3; MANUFACTURED: SEPTEMBER 2013; RETURNED TO MEDTRONIC: FEBRUARY 25, 2014; 510K: K993653; PRODUCT CODE: HET (4) 10MM REDUCTION SLEEVE DIA 5MM (CEV155); LOT: 130702; QUANTITY 3; MANUFACTURED: JULY 2013; RETURNED TO MEDTRONIC: FEBRUARY 25, 2014; 510K: K993653; PRODUCT CODE: HET. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE SHEATH ON FENESTRATED FORCEPS WAS DAMAGED BY AND/OR WHEN USED IN CONJUNCTION WITH A REDUCTION SLEEVE AND TROCARS. THE DAMAGE THE FORCEPS INCURRED CAUSED THE SHEATH TO PEEL OFF IN SUCH A WAY THAT IT PRODUCED DEVICE FRAGMENTS. AS A RESULT, THE ORIGINALLY INTENDED COELIOSCOPY HAD TO DEVIATE FROM ITS COURSE AND TURNED INTO A LAPAROTOMY. AS THIS ADDITIONAL PROCEDURE WAS REQUIRED TO RETRIEVE THE FRAGMENTS FROM INSIDE OF THE PATIENT¿S ABDOMEN. THERE WAS NO REPORT OF PERMANENT IMPACT OR INJURY TO THE PATIENT AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
164468	FORCEPS CEV405 FENESTRATED 350MM JOHANN [MXI/XOM]	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	GEI	XOMED MICROFRANCE MFG	CEV405	130901

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention