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	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis was not able to confirm the customer reported failure mode.The instrument was placed on a in-house system and the self test passed.The instrument delivered energy and cut test was successful.The grip force test was performed and all results passed at straight 5.50, pitch 5.60, and yaw 6.0.The jaw gap test also passed.Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the vessel sealer instrument stopped sealing.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 surgical procedure, the vessel sealer instrument stopped working.There was no report of fragments falling inside the patient.The planned surgical procedure was completed and no patient harm, adverse outcome, or injury was reported.Intuitive surgical, inc.(isi) contacted the site and spoke to the customer who provided the following additional information: the da vinci coordinator stated the vessel sealer was working fine, but then it stopped sealing.There were no error codes or messages indicating the instrument was not sealing.The surgeon was sealing vessels around the colon and noticed he was not seeing any thermal effect on the patient¿s tissue (smoke).She doesn¿t believe the patient had undergone any pre-surgical chemotherapy or radiation treatments.The vessel sealer instrument did not encounter any staples or clips during the sealing cycle.The customer used another vessel sealer instrument to complete the procedure and there was no injury to the patient.There was no video recording done for this procedure.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 7849130
• Report Number: 2955842-2018-10507
• Device Sequence Number: 13820217
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)200331(10)M10180322
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/14/2018

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: M10180322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1