MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CURVED CANNULA ARM2

Model Number 428062-03

Device Problem Break (1069)

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

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the unit involved with the complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure mode.The single site curved cannula was found to have a weld defect.As a result the shaft rotates from the bowel.A field safety notice #: (b)(4) requested for all single-site 5mm curved cannula including part number 428062-03 to be replaced and returned.The complaint is being reported due to the following conclusion: the single site curved cannula has a potential weld defect that could potentially cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the single site curved cannula was observed to be curving the wrong way and was spinning.There was no report of fragments falling inside the patient, patient harm, adverse outcome or injury.

• Brand Name: SINGLE-SITE
• Type of Device: CURVED CANNULA ARM2
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer Contact: tabitha reed ; 950 kifer rd.; sunnyvale ; 4085232100
• MDR Report Key: 7582936
• MDR Text Key: 110595011
• Report Number: 2955842-2018-10272
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 428062-03
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2955842-02-28-2014-001-R
• Patient Sequence Number: 1