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

Model Number 380652-46

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

Patient Problems Abdominal Pain (1685); Urinary Tract Infection (2120); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root causes of the patients' reported postoperative complications cannot be determined or are 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, ¿transvesical approach in robot-assisted bladder diverticulectomy: surgical technique and outcome," it is noted that a patient experienced low abdominal pain after catheter removal and was treated with interertion of a transurethral catheter for an additional 5 days. At this time the root cause of the post-operative abdominal pain is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.

Event Description

On 11-mar-2022, intuitive became aware of a "journal of endourology" article titled, ¿transvesical approach in robot-assisted bladder diverticulectomy: surgical ttechnique and outcome¿ (develtere, d. , mazzone, e. , et al. , 2022). The outcomes of 23 patients who underwent a transvesical robot-assisted bladder diverticulectomy (rabd) between march 2015 and may 2020 were analyzed. Within the journal article, post-operative complications involving a da vinci surgical procedure were noted. ¿one patient experienced low abdominal pain after catheter removal which was suspicious for urinary leakage and was treated with insertion of a transurethral catheter for additional 5 days (with complete symptom resolution after catheter removal). One patient developed a uti. No other early postoperative complications were recorded. " additionally, no intra-operative complications were reported and no late post-operative complications were recorded. Isi has reached out to the author to obtain additional information but has not yet received a response.

• 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: 14059717
• MDR Text Key: 293697897
• Report Number: 2955842-2022-10954
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

0 Patients were 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

• Device Model Number: 380652-46
• 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: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2019
• 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