FDA Adverse Event Malfunction Summary report: N

PROXIMATE I L S INTRALUMINAL STAPLER

MDR report key: 79375 · Received January 30, 1997

Report

Report Number: 1628808-1997-00072
Event Type: Malfunction
Date Received: January 30, 1997
Date of Event: November 3, 1996
Report Date: January 30, 1997
Manufacturer: EES-ALBUQUERQUE
Product Code: GAG
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

BASED ON THE INFO RECEIVED AND THE VISUAL RESULTS, IT APPEARS LIKELY THAT THE SECOND FIRING OF THE INSTRUMENT MAY HAVE CAUSED THE REPORTED INCIDENT. AS THE INSTRUMENT IS A SINGLE USE INSTRUMENT, A SECOND FIRING OF THE INSTRUMENT WILL NOT DELIVER STAPLES, THEREFORE, FIRING THE INSTRUMENT MORE THAN ONCE IS CONTRAINDICATED. DURING ANALYSIS, IT WAS NOTED THAT ONE MANGLED STAPLE WAS RETURNED IN THE INSTRUMENT. IT APPEARS POSSIBLE THA THE ANASTOMOSIS MAY HAVE BEEN DISRUPTED AND THE STAPLES MAY HAVE BEEN CUT OUT DURING THE SECOND FIRING OF THE INSTRUMENT. MANUFACTURING AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

Description of Event or Problem · 1

THE DEVICE WAS USED DURING A RECTO SIGMOID RESECTION (LOW ANTERIOR RESECTION). IT WAS REPORTED BY THE AFFILIATE THAT ALL THE STEPS BEFORE FIRING SEEMED TO BE DONE CORRECTLY. THE DEVICE WAS FIRED MORE THAN ONE TIME. THE AFFILIATE REPORTED THAT HE WAS NOT SURE THAT THE KNOB WAS TURNED ANTI CLOCK WISE. THE ANASTOMOSIS WAS TOTALLY INCOMPLETE. THE DEVICE DID NOT FIRE ANY STAPLES. THE PROCEDURE WAS COMPLETED BY SUTURING THE ANASTOMOSIS. IT WAS REPORTED THAT THERE WAS NO CONSEQUENCE TO THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROXIMATE I L S INTRALUMINAL STAPLER	CIRCULAR STAPLERS	GAG	EES-ALBUQUERQUE	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other