MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. ENDOWRIST ONE VESSEL SEALER; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 410322-05

Device Problems Electrical /Electronic Property Problem (1198); Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211)

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

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed investigations.Failure analysis investigations replicated and confirmed the customer reported complaint.The instrument was installed on in-house system and passed the self-check test.The instrument moved intuitively with a full range of motion.The instrument passed cut and seal functional testing with no issues.The instrument passed grip force testing in all wrist orientations and passed electrical continuity testing.The instrument failed gap gage testing; the instrument's gage measured 0.001 indicating that space between the electrodes was below specifications.Review of the instrument's logs for the reported procedure date, found that during use of the instrument, there were 31 incomplete cuts followed by complete cuts.The seals were found to be complete.No other damage was found.Based on the information provided, this complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, the endowrist one vessel sealer instrument did not correctly seal the patient's tissue adequately.While there was no harm to the patient, recurrence of the reported failure mode could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted right hemicolectomy procedure, the endowrist one vessel sealer instrument did not correctly seal the patient's tissue.The planned surgical procedure was completed and there was no report of any patient harm, adverse outcome or injury.

• Brand Name: ENDOWRIST ONE VESSEL SEALER
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• 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: 6831857
• MDR Text Key: 84406821
• Report Number: 2955842-2017-00581
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111116
• UDI-Public: (01)00886874111116(17)160930(10)M11160915
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322-05
• Device Lot Number: M11160915 380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1