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	08/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The vessel sealer instrument involved with this complaint has not been received for evaluation; therefore the root cause of the customer reported failure mode cannot be determined.If additional information is received, a follow up mdr will be submitted.Based on the information provided, this complaint is being reported due to following conclusions: it was alleged that during a da vinci-assisted surgical procedure, the vessel sealer instrument was not sealing properly.Although, no patient harm was reported reoccurrence of the reported failure could cause or contribute to an adverse event, if the malfunction were to recur.
Event or Problem Description
It was reported that during a da vinci-assisted sigmoid colectomy procedure, the surgical staff noted that the vessel sealer instrument was not sealing/cauterizing tissue properly.The surgeon had difficulty sealing thicker tissue properly.There was no report of fragments falling inside the patient.There was no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: a second vessel sealer instrument was opened to complete the procedure robotically.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 8091716
• Report Number: 2955842-2018-10685
• Device Sequence Number: 1225313
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)190228(10)M13170208
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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: M13170208 0051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1