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	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instrument has not been returned for evaluation; therefore, the root cause of the customer reported event cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the surgeon alleged that the endowrist vessel sealer instrument did not seal and the patient experienced bleeding.As a result the surgeon placed sutures on the vessel to control the bleeding.At this time, the root cause of the customer reported event is unknown.
Event or Problem Description
It was reported that during a da vinci-assisted sigmoid colectomy procedure, the surgeon alleged that the endowrist vessel sealer instrument "did not seal¿ and the patient experienced bleeding.As a result, the surgeon placed sutures on the artery to control the bleeding.On 15-jun-2018, the intuitive surgical, inc.(isi) clinical sales representative (csr) who was present during the procedure provided the following additional details regarding the reported event: it was reported that the surgeon was able to use the endowrist vessel sealer instrument without any issues up until the event occurred.The surgeon was attempting to seal the pedicle of the inferior mesenteric artery (ima) vessel.After sealing, the surgeon observed that the stump appeared to be short and then began to bleed from the stump.The surgeon was able to control the bleeding by placing sutures.According to the csr the patient experienced unspecified amount of blood loss; however, it was confirmed there was no blood transfusion administered.The csr confirmed the following: that they heard the audible tones indicating that the sealing cycle was complete, the vessel was not calcified, and not more than 7mm in diameter.The planned surgical procedure was completed robotically with no further issues.There is a video recording of this procedure, isi has attempted to obtain a copy of the recording; however, as of the date of this report, isi has not received a copy of the video recording.Isi was unable to gather additional details regarding the electrosurgical unit (esu) settings.

• Brand Name: ENDOWRIST
• Common Device Name: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7667857
• Report Number: 2955842-2018-10349
• Device Sequence Number: 1619033
• Product Code: NAY
• UDI-Device Identifier: 10886874112745
• UDI-Public: (01)10886874112745(17)200331(10)M10180327
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K140189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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: M10180327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/06/2018
• 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: Required Intervention