MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. CANNULA SEAL

Device Problem Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

The cannula seal accessory will not be returned to isi for failure analysis investigation as it was confirmed that it was discarded.Therefore, the customer reported failure has not been been determined.If additional information is received, a follow-up mdr will be submitted to the fda.This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure a fragment from the cannula seal accessory broke off and fell inside the patient.The fragment was retrieved, however, at this time it is unknown what caused the breakage to occur.

Event Description

It was reported that during a da vinci-assisted inguinal hernia repair procedure, a piece of an unspecified cannula seal accessory broke off and fell inside patient and was retrieved.There was no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) obtained the following additional information from the initial reporter: the initial reporter confirmed that the broken fragment was retrieved immediately with no additional medical intervention.It was also confirmed that the cannula seal accessory would not be returned to isi.

• Brand Name: CANNULA SEAL
• 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 ; 4085232420
• MDR Report Key: 6755693
• MDR Text Key: 81575794
• Report Number: 2955842-2017-00500
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1