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	Blood Loss (2597)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Isi has requested for the site to return the instrument for evaluation.As of the date of this report, the instrument has not been returned to isi.If additional information is obtained, a follow-up mdr will be submitted.Isi has reviewed the site's system logs with a procedure date of 08/01/2018.No related system errors were found to have occurred during the surgical procedure.Based on the current information provided, this complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the endowrist vessel sealer instrument allegedly failed to seal a vessel and as a result, the patient lost 900 ml of blood.However, at this time, the root cause of the customer reported issue is unknown.
Event or Problem Description
It was initially reported that during a da vinci-assisted sigmoid colectomy procedure, the surgeon attempted to seal an artery at the proximal and distal ends using an endowrist vessel sealer instrument.The surgeon claimed that the instrument failed to seal at both locations.According to the initial reporter, there was no tension on the artery and the surgeon had cleared fat from around the vessel.The patient lost an unspecified amount of blood but the surgical staff was able to control the bleeding.The initial reporter indicated that the patient was fine.On (b)(6) 2018, intuitive surgical, inc.(isi) contacted the initial reporter and obtained the following additional information regarding the reported event: she was not present during the surgical procedure.There were no reported error messages when the event occurred.The initial reporter did not know if the surgeon saw tissue effect while attempting to seal the vessel in question.The initial reporter indicated that the endowrist vessel sealer instrument was working at the beginning of the surgical procedure.When the event occurred, the patient lost 900 ml of blood.However, the initial reporter did not know what specific actions the surgical staff took to control the bleeding.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 7811259
• Report Number: 2955842-2018-10482
• Device Sequence Number: 1143007
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)200331(10)M11180320
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 480322-07
• Device Lot Number: M11180320 0358
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention