ENDOPATH ENDOSCOPIC MULTIFEED STAPLER

MDR report key: 85034 · Received April 15, 1997

Report

Report Number: 9680598-1997-00083
Event Type: Malfunction
Date Received: April 15, 1997
Date of Event: January 28, 1997
Report Date: April 8, 1997
Manufacturer: EES-JUAREZ
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

CARTRIDGE NOSE BOTTOM CRACKED.

Description of Event or Problem · 1

DURING A LAPAROSCOPIC HERNIA REPAIR THE SURGEON FIRED THE EMS ONTO COOPERS LIGAMENT AND NO STAPLE CAME OUT. THE DEVICE WAS FIRED SEVERAL MORE TIMES AND NO STAPLES CAME OUT. A SECOND DEVICE WAS OPENED AND THE SAME EVENT OCCURRED. A THIRD DEVICE WAS OPENED AND PERFORMED PERFECTLY. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 1/31/97 14 ATTEMPTED TO CONTACT SURGEON AND THERE WAS NOT ANSWER. 1/31/97 1640 MESSAGE AND 800 NUMBER LEFT FOR THE SURGEON TO CALL BACK.2/3/97 1825 NNCL SENT. 2/17/97 1121 SURGEON CALLED AND CONFIRMED THE INFO AS REPORTED BY THE REP. HE STATED HE WAS USING THE INSTRUMENTS APPROPRIATELY AND HAD NOT DRY-FIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOPATH ENDOSCOPIC MULTIFEED STAPLER	ENDOSCOPIC STAPLER	GAG	EES-JUAREZ	NA	EH8786

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other
2