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	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endowrist vessel sealer instrument has not been returned to isi for failure analysis evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to the reported event.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 vessel sealer instrument intermittently sealed the patient¿s tissue.There was no report of any patient harm or adverse outcome.However, it is unknown what caused the vessel sealing issue experienced by the surgeon.
Event or Problem Description
It was reported that during a da vinci-assisted bladder neck suspension procedure, the surgeon noted that two vessel sealer instruments were not cauterizing.The customer informed the intuitive surgical, inc.(isi) technical support that all indicators occurred with the vessel sealer but there was no energy.The customer checked both energy ports for the vessel sealer was recommended to attempt the vessel sealer on another arm.The customer moved the vessel sealer to arm #2 and the instrument energized when activated.Then requested the customer to reseat the sterile adapter on arm #4 and attempt the vessel sealer again.The vessel sealer energy activated on arm #4 after the sterile adapter was reseated.The planned surgical procedure was completed and there was no report of any patient harm, adverse outcome or injury.On 12-jun-2018, isi received additional information from the isi clinical sales representative (csr) who initially reported this complaint: the isi csr indicated that she was unsure whether they heard the audible tones and no thermal effect was noted on the tissue.There were no error messages when the grips were opened and it was noticed that no energy was generated.The csr is unaware of the patient's tissue characteristics.She stated that there was no unintentional patient bleeding due to this issue.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7639398
• Report Number: 2955842-2018-10318
• Device Sequence Number: 1556083
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)200229(10)M11180227
• 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): 06/01/2018

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: M11180227 0073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1