FDA Adverse Event Malfunction Summary report: N

ENDOPATH PNEUMOPERITONEUM NEEDLE

MDR report key: 82071 · Received January 28, 1997

Report

Report Number: 1218017-1997-00013
Event Type: Malfunction
Date Received: January 28, 1997
Report Date: January 28, 1997
Manufacturer: LACEY MFG CO.
Product Code: FHP
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

H6; CODE 400: FEEDBAR WAS ADHERED TO THE APPLIER FLOOR AND FEED BAR TIMP WAS UNRAVELED. BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED INCIDENT DURING SURGERY MAY HAVE BEEN DUE TO DRIED BODY FLUIDS ADHERING THE FEED BAR TO THE APPLIER FLOOR. THE INSTRUMENT WAS RECEIVED WITH EXCESSIVE DRIED BODY FLUIDS IN THE CARTRIDGE ASSEMBLY. THE FEEDBAR WAS ADHERED TO THE APPLIER FLOOR AND THE FEEDBAR TIP WAS UNRAVELED. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE UNRAVELED FEEDBAR. THE CARTRIDGE WAS OBSERVED TO CONTAIN 13 CLIPS. COMMENTS: BRIEFLY SWISHING THE APPLIER WITH SALINE BETWEEN USES WILL REDUCE THE OCCURRENCE OF THIS INCIDENT. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE PRODUCTS.

Description of Event or Problem · 1

DURING A LAPAROSCOPIC TUBAL LIGATION, THE SURGEON SAID THE DEVICE IS NOT LONG ENOUGH FOR OBESE PTS. IT TOOK ALMOST TEN MINUTES TO INSUFFLATE BECAUSE THE DEVICE WAS TOO SHORT. EVENTUALLY THE PN150 WENT THROUGH THE PERITONEUM AND INSUFFLATED SUCCESSFULLY. THERE WAS NO CONSEQUENCE TO THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDOPATH PNEUMOPERITONEUM NEEDLE	PNEUMOPERITONEUM NEEDLE	FHP	LACEY MFG CO.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other