MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER

Model Number	480322-07
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the vessel sealer instrument was not sealing properly.While there was no report of any patient, harm, adverse outcome or injury, recurrence of the reported failure mode could cause or contribute to an adverse event.
Event or Problem Description
It was reported that during a da vinci-assisted total colectomy procedure, the vessel sealer instrument was not sealing properly.The customer stated that an insufficient amount of energy was applied to the instrument tips.The customer stated that the "tissue bites" were not larger than normal and that the instrument gave indications that the sealing was complete but was not fully sealing the tissue.The vessel sealer instrument was used for approximately seven fires before it was swapped out to another vessel sealer instrument.However, the issue persisted and once again the instrument was swapped out.The procedure was completed with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the patient did not experience any bleeding, an error message was displayed before cutting, however, it is unknown what the error message was.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the vessel sealer involved with this complaint and completed the device evaluation.Failure analysis did not confirm the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the self-test, electrical continuity test, and recognized the erbe generator unit on multiple attempts.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly, energy delivery test was performed and passed.Performed grip force test on grips as additional testing, and it measured at 6.28 lbf in straight orientation, 5.98 lbf in yaw, and 6.0 lbf for pitch.All readings were above the minimum requirement of 4.25 lbf.Electrode gap inspection was tested as an additional functional check.Electrode gap test passed.In addition, verified gap between grips was.002", which is within range of.001" and.007".

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 8067197
• Report Number: 2955842-2018-10669
• Device Sequence Number: 19430486
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)200630(10)M10180615
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 480322-07
• Device Lot Number: M10180615 0371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES