55MM SELECTABLE NEW TLC

MDR report key: 1912418 · Received December 2, 2010

Report

Report Number: 3005075853-2010-06803
Event Type: Injury
Date Received: December 2, 2010
Date of Event: October 10, 2010
Report Date: November 11, 2010
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDW
PMA / PMN Number: K092577
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT POST OP OF A COLON RESECTION ON (B)(6) 2010, ON THE NEXT DAY THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR AN EMERGENCY EXPLORATORY PROCEDURE. WHEN THE SURGEON OBSERVED THE STAPLE LINE AT THE ANASTOMOSIS SITE, HE SAW BLEEDING AND A STAPLE LINE LEAK. HE THEN USED SUTURE TO SECURE THE STAPLE LINE AND COMPLETED THE PROCEDURE. THERE WERE NO BLOOD PRODUCTS REQUIRED. NO INFECTION REPORTED. NO OTHER INFORMATION WAS AVAILABLE AT THIS TIME. THE PATIENT IS STABLE AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Description of Event or Problem · 1

MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION AND NO INFORMATION WAS RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	55MM SELECTABLE NEW TLC	STAPLE, IMPLANTABLE	GDW	ETHICON ENDO-SURGERY, LLC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R	CARTRIDGE