MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, 4-ARM

Model Number 380614-04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Hematoma (1884); Unspecified Tissue Injury (4559)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Therefore, no product is expected to be returned.A follow-up mdr will be submitted if additional information is obtained.The following investigations could not be performed due to insufficient information provided (i.E.Event date): site complaint history review, event verification, system/instrument log review.This event is being reported due to the following conclusion: it was reported that eight patients experienced complications involved with a da vinci-assisted hysterectomy.One patient required an intra-operative conversion to open.Seven patients experienced post-operative complications which required medication to resolve.

Event Description

On 12-jan-2022, intuitive surgical inc.(isi) became aware of a journal of robotic surgery article titled, ¿surgical outcome for robotic-assisted single-site hysterectomy (rssh) in female-to male reassignment compared to its use in benign gynecological disease: a single center experience¿ (gardella, b., dominoni, m., et al., 2021).Within the journal article, operative complications involving a da vinci surgical procedure were noted: ¿during the robotic procedures, no mechanical problems or adverse events related to the use of robotic equipment were reported.We completed a robotic single-site procedure in all of the transgender men (tm), while in only 1 cisgender woman (cw) we needed to resort to a laparotomy.One dindo grade ii complication (bladder injury) was reported in the cw group, while no intra-operative complications were seen in the tm group.There was no difference between both groups in relation to early post-operatory complications: all of these were dindo grade ii and iii and were in the tm group (2 with fever, 1 cystitis) while 4 in the other group (2 with fever, 1 anemia, 1 cystitis)." on 26-jan-2022, isi contacted the author(s) of this article and additional information was obtained: the reporter stated that no da vinci product malfunctions occurred during these procedures.All the instruments were inspected prior to use with no abnormalities noticed.The four patients who experienced post-operative fevers and two patients who experienced post-operative cystitis were treated with antibiotics.In regards to the post-operative fevers and post-operative cystitis cases, the author replied that the cause was, "average incidence of post-operative complication." the patient who experienced post-operative anemia was treated with an ¿iron-base cure.¿ when asked what the surgeon believes the cause of this complications was the reporter answered, ¿0.83% incidence of post-operative complication.¿ one patient sustained a bladder injury intra-operatively which required a conversion to open surgery.The reporter said there was no malfunction of a da vinci product during this procedure.The surgeon was separating the bladder and uterus and encountered adhesion when the injury occurred.The reporter stated the cause of the complication was ¿adhesions between bladder and uterus.¿ this patient reportedly did not experience any post-operative complications.

• Brand Name: DAVINCI SI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 13471400
• MDR Text Key: 289460180
• Report Number: 2955842-2022-10188
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380614-04
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female