MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM INSTRUMENT CANNULA; ENDOSCOPIC ACCESSORY

Model Number 420002-07

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the accessory involved with this complaint and completed investigation.Failure analysis investigation found the cannula weld that joins the tube and the bowl was cracked around the circumference.Since the orientation of the tube relative to the bowl was critical to the function of the item, the cannula could not be used.This complaint is being reported because the cannula accessory broke and fell into the patient.The broken piece was retrieved during the same procedure and there was no report of patient injury/ harm.

Event Description

It was reported that during a da vinci surgical procedure, the cannula accessory came apart and fell into the patient as it was being removed.On (b)(6) 2015, intuitive surgical, inc.(isi) obtained additional information from the reporter.The cannula was inspected prior to use.It is not known what may have caused the cannula to break.The fragment was retrieved during the same procedure.The planned procedure was completed and no patient harm, adverse out of injury was reported.

Manufacturer Narrative

Based on additional information obtained from advance failure analysis (afa), the reported complaint and primary finding was confirmed.There was evidence of a weld at the bowl and tube interface, but it was found cracked around the interface.The cannula was evaluated further and found to have several gouges on the bowl and a bent tube opening that resulted in a failed gage pin test.The tube also exhibited scratch marks across the entire surface that likely corresponds with the use of an object used to scrub during reprocessing.Based on these additional findings, there is evidence of mishandling/ misuse.Based on the additional advanced failure analysis investigation, this mdr report is being retracted since the failure was due to misuse/ mishandling and not due to a malfunction of the instrument.

• Brand Name: 8 MM INSTRUMENT CANNULA
• Type of Device: ENDOSCOPIC ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA
• MDR Report Key: 5088723
• MDR Text Key: 26484697
• Report Number: 2955842-2015-01222
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420002-07
• Device Lot Number: VE123204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1