FDA Adverse Event Malfunction Summary report: N

PROXIMATE I L S INTRALUMINAL STAPLER

MDR report key: 82205 · Received February 27, 1997

Report

Report Number: 1628808-1997-00080
Event Type: Malfunction
Date Received: February 27, 1997
Date of Event: January 22, 1997
Report Date: February 26, 1997
Manufacturer: EES-ALBUQUERQUE
Product Code: GAG
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS EXAMINED FOR PROTRUDING STAPLES WITH NONE NOTED. HOWEVER, IT HAS BEEN OBSERVED THAT THE CONDITION OF PROTRUDING STAPLES CAN BE CREATED IF THE ADJUSTING KNOB IS DIALED OPEN TOO FAR OR BEYOND THE POINT WHERE THE ADJUSTING KNOB PROVIDES RESISTANCE ONCE THE ORANGE TYING AREA IS VISIBLE. AS STATED IN THE PACKAGING INSERT, THE INSTRUMENT SHOULD BE OPENED ONLY UNTIL THE ORANGE TYING AREA IS CLEARLY VISIBLE ABOVE THE STAPLE HOUSING. MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE THE PROUDUCTS.

Description of Event or Problem · 1

DURING A LOW ANTERIOR RESECTION THE CDH25 SAFETY NEVER RELEASED. THE TIPS OF THE STAPLES WERE EXPOSED WHEN THE INSTRUMENT WAS OPENED FOR USE. THE INSTRUMENT WAS NOT USED. ANOTHER CDH25 WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 1/31/97 1115 MESSAGE AND 800# LEFT FOR MD CALL BACK. 2/3/97 1740 NNCL SENT.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other