FDA Adverse Event Malfunction Summary report: N

CANNULA, 8MM, REGULAR, IS2000

MDR report key: 919536 · Received September 21, 2007

Report

Report Number: 2955842-2007-00334
Event Type: Malfunction
Date Received: September 21, 2007
Report Date: September 21, 2007
Manufacturer: INTUITIVE SURGICAL, INC.
Product Code: GCJ
Removal / Correction Number: 2955842-2/22/07-001-R
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE ACCESSORY WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT THE CANNULA WAS VISIBLY DENTED AT THE DISTAL TIP AND IT APPEARS THAT THE DAMAGE WAS MOST LIKELY CAUSED BY USER HANDLING. IT WAS DETERMINED THAT THE TIP DEFORMATION HAS THE POTENTIAL TO CAUSE INSTRUMENT SCRAPING IN CERTAIN LOADING CONDITIONS. NO OTHER DAMAGE WAS FOUND. THE SITE HAS PREVIOUSLY RETURNED SCRAPED INSTRUMENTS WHERE IT WAS DETERMINED THE SCRAPING WAS MOST LIKELY CAUSED BY A POTENTIALLY DEFECTIVE CANNULA ACCESSORY. THE FOLLOWING MEDWATCH REPORTS WERE SENT TO THE FDA REGARDING THESE INSTRUMENTS. MFR REPORT #2955842-2007-00040. MFR REPORT # 2955842-2007-00220. MFR REPORT# 2955842-2007-00183.

Description of Event or Problem · 1

THE CANNULA ACCESSORY WAS RETURNED AS PART OF A FIELD REMOVAL ACTION. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE FOLLOWING MEDWATCH REPORTS LISTED BELOW WERE ALSO SENT TO THE FDA. THESE REPORTS ONLY PERTAIN TO THE FIELD REMOVAL ACTION FROM THIS SPECIFIC SITE. MFR REPORT # 2955842-2007-00335, MFR REPORT #2955842-2007-00336. MFT REPORT #2955842-2007-00337, MFT. REPORT # 2955842-2007-00338, MFR. REPORT # 2955842-2007-00339.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CANNULA, 8MM, REGULAR, IS2000	ENDOSCOPIC ACCESSORY	GCJ	INTUITIVE SURGICAL, INC.	420002-01	SA062502

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR			DA VINCI S SURGICAL SYSTEM AND INSTRUMENTS