FDA Adverse Event Malfunction Summary report: N

ENDOPATH TRISTAR EXTRAPERITONEAL DISSECTOR

MDR report key: 89057 · Received May 4, 1997

Report

Report Number: 1527736-1997-00835
Event Type: Malfunction
Date Received: May 4, 1997
Date of Event: April 4, 1997
Report Date: April 29, 1997
Manufacturer: ETHICON ENDO-SURGERY, INC.
Product Code: GCJ
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH TRISTAR EXTRAPERITONEAL DISSECTOR WHILE PERFORMING A LAP HERNIA REPAIR. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972176. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BALLOON CONDITION, CAM CONDITION, DESUFFLATION LEVER CONDITION, EXTENSION CONDITION, INNER GASKET CONDITION, OUTER GASKET CONDITION, SLEEVE CONDITION, AND STOPCOCK CONDITION, UNK. FUNCTIONAL TESTS & RESULTS: BALLOON INFLATION TEST, NA. ANALYSIS CONCLUSION: RECORD PURPOSES ONLY: NO ANALYSIS COULD BE PERFORMED SINCE NO INSTRUMENT WAS RECEIVED. THE INFO PROVIDED HAS BEEN NOTED AND REVIEWED WITH THE APPROPRIATE MFG AND ENGINEERING PERSONNEL. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

Description of Event or Problem · 1

THE TED12 WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. THE BALLOON POPPED DURING THE SURGERY. THERE IS NO OTHER INFO AVAILABLE AT THIS TIME. THERE WAS NO CONSEQUENCE TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOPATH TRISTAR EXTRAPERITONEAL DISSECTOR	DISSECTOR	GCJ	ETHICON ENDO-SURGERY, INC.	NA	K4600T

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other