PROXIMATE I L S INTRALUMINAL STAPLER

MDR report key: 60376 · Received January 2, 1997

Report

Report Number: 1628808-1996-00329
Event Type: Malfunction
Date Received: January 2, 1997
Date of Event: December 6, 1996
Report Date: December 31, 1996
Manufacturer: ETHICON ENDO-SURGERY, INC.
Product Code: GAG
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

D6: INFO UNAVAILABLE, DEVICE WAS NOT RETURNED FOR ANALYSIS.

Description of Event or Problem · 1

DURING A LOW ANTERIOR RESECTION THE CDH33 STAPLES MALFORMED CAUSING A PERFORATION IN THE RECTAL STUMP. THE SURGEON FIRED AN AX55 LOWER THEN USED ANOTHER CDH33 LOWER INTO THE PELVIS SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PT. 12/11/96 1540 SURGEON RETURNED CALL. HE STATED HE INSERTED THE DEVICE THROUGH THE RECTUM AND PLACED THE ANVIL ON THE TROCAR AND CLOSED IT WITHIN THE FIRING RANGE. HE TRIED TO FIRE THE DEVICE AND COULD NOT CLOSE THE HANDLE TO FIRE IT. HE OPENED THE DEVICE, RECLOSED IT WITHIN THE FIRING RANGE AND ATTEMPTED TO FIRE IT. ONCE AGAIN HE COULD NOT FIRE IT AND HE DID NOT HEAR OR FEEL THE AUDIBLE/TACTILE FEEDBACK. WHEN HE OPENED THE DEVICE HE NOTED SOME STAPLES HAD BEEN PARTIALLY PUSHED OUT AND PARTIALLY FORMED. HE RESECTED FURTHER DOWN ON THE RECTUM, WHICH HE WAS COMFORTABLE WITH TO INCREASE HIS MARGIN SIZE. A SECOND DEVICE WAS OPENED AND FIRED WITHOUT PROBLEMS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROXIMATE I L S INTRALUMINAL STAPLER	CIRCULAR STAPLERS	GAG	ETHICON ENDO-SURGERY, INC.	NA	J4359K

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other