FDA Adverse Event Malfunction Summary report: N

ENDOPATH ELECTROSURGERY PROBE PLUS II

MDR report key: 139533 · Received December 19, 1997

Report

Report Number: 1527736-1997-03503
Event Type: Malfunction
Date Received: December 19, 1997
Date of Event: October 7, 1997
Report Date: November 21, 1997
Manufacturer: ETHICON ENDO-SURGERY, INC.
Product Code: KNS
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. FUNCTIONAL TESTS & RESULTS: INSTRUMENT (S) FUNCTION PROPERLY, BCF)NO,ADEG)YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, VISUAL EXAMINATION AND FUNCTIONAL TEST, IT WAS CONCLUDED THAT THE REPORTED "RIGHT ANGLED ELECTRODES FELL OFF THE THREE DEVICES "DURING SURGERY OCCURRED DUE TO AN INADEQUATE SOLDER WELD ON INSTRUMENTS (B), (C), AND (F). INSTRUMENTS (A), (D), (E), AND (G) WERE REC'D IN GOOD PHYSICAL CONDITION. THE ELECTRODE TIP IS WELDED DURING THE ASSEMBLY PROCESS. THE ASSEMBLY WELD EQUIPMENT HAS BEEN MODIFIED TO REDUCE THE POSSIBILITY OF THE RECURRENCE OF THIS ISSUE.

Description of Event or Problem · 1

IT WAS REPORTED THE DEVICES WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE RIGHT ANGLED ELECTRODES FELL OFF OF THREE DEVICES INTO THE PT'S ABDOMEN. THE ELECTRODES WERE RETRIEVED BY USING GRASPING FORCEPS. ALL ELECTRODES WERE RECOVERED. THERE WAS NO PT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOPATH ELECTROSURGERY PROBE PLUS II	ELECTROSURGERY	KNS	ETHICON ENDO-SURGERY, INC.	NA	J4SF39

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other