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

Model Number 380652-31

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

Patient Problems Urinary Tract Infection (2120); Stenosis (2263); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

On 09-mar-2022, intuitive surgical, inc.(isi) became aware of a "journal of robotic surgery" article titled, ¿robotic-assisted laparoscopic pyeloplasty (ralp), for ureteropelvic junction obstruction (upjo), is an alternative to open pyeloplasty in the pediatric population¿ (cohen, s., raisin, g., et al., 2021).Within the journal article, post-operative complications involving a da vinci surgical procedure were noted.The clinical article cited that study data was collected based on a retrospective review of records of all patients with upjo who underwent ralp at a single institution between december 2016 and april 2021.The purpose of the study was to evaluate the safety and efficacy of ralp for upjo in a heterogenous pediatric population.The study examined two groups: low-weight children (<10kg) and those who underwent ralp after failed pyeloplasty.Within the journal article, 8 post-operative complications were noted.Two patients experienced failed ralp with one patient requiring a redo ralp, and six patients had clavien-dindo grade i-ii complications (urinary tract infections (5), post-operative paralytic ileus (1)).One patient experienced a clavien-dindo grade iiib complication (i.E.Stricture of anastomosis).One other patient experienced an unspecified clavien-dindo grade iiib complication.Ninety-eight percent of the patients showed improvement or stable hydronephrosis on postoperative imaging, with a better drainage curve on dynamic radionuclide scans.The authors concluded that pediatric patients with upjo may benefit from ralp as a universal approach.Isi has attempted to contact the author to obtain additional information, but has not yet received a response.

Manufacturer Narrative

Based on the current information provided, the root causes of the reported complications after undergoing ralp cannot be determined or is unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.If additional information is received, a follow-up mdr will be submitted.There was no image or video clip supplied for review related to a specific event.System or instrument log reviews could not be performed due to a lack of system, procedure, and instrument detail.This complaint is being reported due to the following conclusion: within the journal article titled, ¿robotic-assisted laparoscopic pyeloplasty (ralp), for ureteropelvic junction obstruction (upjo), is an alternative to open pyeloplasty in the pediatric population," it is noted that 8 post-operative complications occurred.The causes of the patients' complications are unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred or caused/contributed to the complications.

• Brand Name: DAVINCI XI
• 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: 14055775
• MDR Text Key: 289607297
• Report Number: 2955842-2022-10946
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K131861
• 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: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-31
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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