MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MONOPOLAR CURVED SCISSORS

Model Number 420179-18

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the patient's intra-operative complication cannot be determined.Isi has attempted to contact the site's risk management department to obtain additional information regarding the reported event.However, as of the date of this report, no new information has been obtained.If additional information is obtained, a follow-up mdr will be submitted.Isi has reviewed the site's system logs based on the part # and lot # of the monopolar curved scissors instrument noted in the fda voluntary report.The system logs reveal that the monopolar curved scissors instrument in question was last used on (b)(6) 2018.No related system errors were found to have occurred during the surgical procedure based on the available system logs.However, the event date of the reported incident has not been confirmed.This complaint is being reported due to the following conclusion: during a da vinci-assisted hysterectomy procedure, the patient allegedly sustained a thermal burn injury to the bladder dome that required repair.At the time the event occurred, the surgeon was using a monopolar curved scissors instrument.It is unknown, however, how the thermal burn injury occurred.

Event Description

On 02/05/2020, intuitive surgical, inc.(isi) received fda uf/importer reporter # (b)(4) with the following event description: "while undergoing a robotic assisted laparoscopic total hysterectomy the monopolar curved scissors caused a thermal injury to the patients bladder dome.This was identified and repaired intra-operatively with over sew of the bladder dome.¿ the following information is unknown: the specific date the event occurred in (b)(6) 2018, what surgical task the surgeon was performing when the burn injury occurred, the severity of the burn injury, the procedure outcome, and the patient's current status.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: MONOPOLAR CURVED SCISSORS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 9742171
• MDR Text Key: 191823790
• Report Number: 2955842-2020-10131
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111505
• UDI-Public: (01)00886874111505(10)N12180517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420179-18
• Device Lot Number: N12180517 664
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention