MAUDE Adverse Event Report: DAVINCI SI; PATIENT SIDE CART, 4-ARM, RECERTIFIED

Model Number	380675-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, during a da vinci-assisted low anterior resection procedure, severe adhesions were encountered during the inferior mesentery artery (ima) treatment resulting in insufficient identification of the anatomy.As a result, the ima was torn during the procedure, and the patient experienced bleeding.At that time, the procedure was converted to a laparotomy (open procedure).The surgeon was able to control the bleeding with sutures and continue the procedure without major problems after converting to an open surgical procedure.The surgeon stated there was no allegation that a da vinci system, instrument or accessory did not function as intended.The surgeon indicated that the bleeding resulted from an injury of the ima due to the difficulty of anatomic identification, due to the severe adhesions.On 05-oct-2021, intuitive surgical, inc.(isi) contacted the site and obtained the following additional information regarding the reported event.It was reported that the fenestrated bipolar instrument was installed on the left arm, the monopolar curved scissors on the right arm, and the double fenestrated grasper instruments on the third arm.It was unspecified on which part of the anatomy the adhesions were present.The ima anatomy was complicated, and the surrounding tissues were adherent.It was unknown which specific instrument was used for the adhesiolysis and involved in the ima injury.It was unknown if the vessel injury was clean-cut or thermal damage.However, it was confirmed that there was no malfunction of an isi system or instrument that occurred.The surgeon reported that the bleeding was related to the adhesions, and the tissue structure was not well identified due to the complexity of vascular running.It is unknown if the bleeding was induced by da vinci instrument or assistant forceps.It was confirmed that there was only a small amount of bleeding as it was controlled in a timely manner.The procedure was converted to an open procedure, and the ima was repaired with sutures.The patient is reported to be recovering well with no post-operative complications.The patient-related details were not provided.There were no video recording or images available for review.It was reiterated that the vessel injury was caused by severe adhesions and insufficient identification of the tissue structure, and there was no relationship with the medical device.
Additional Manufacturer Narrative
Based on the current information provided, the root cause of the customer reported issue is related to patient anatomy.If additional information is received, a follow-up mdr will be submitted.There was no initial report or any known allegation from the medical professional of a specific deficiency of the da vinci system, instrumentation, or accessories associated with the reported incident.Therefore, no products are expected to return to isi for failure analysis evaluation.A review of the system logs associated with this event has been performed.The investigation revealed there were no errors during this procedure.Moreover, the three instruments that were in use during the vessel injury have been used in subsequent procedures.Site complaint history reviews have shown that no complaints were filed against the instruments.A review of the site's complaint history does not reveal any complaints involving this product or this event.No image or video recording has been provided for isi review.This complaint is reportable due to the following conclusion: during a da vinci-assisted lower anterior resection procedure, severe adhesions were reportedly identified during treatment of the ima and the anatomy was insufficiently identified.As a result, the ima tore during the procedure, and the patient experienced bleeding.The procedure was converted to an open surgical procedure, and the bleeding was controlled with sutures.The root cause of the ima injury was related to patient anatomy.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, 4-ARM, RECERTIFIED
• MDR Report Key: 12694454
• Report Number: 2955842-2021-11383
• Device Sequence Number: 4238154
• Product Code: NAY
• UDI-Device Identifier: 00886874110737
• UDI-Public: (01)00886874110737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 380675-04
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES