MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ENDOSCOPE

Model Number 470056

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure that arm 2 had a recoverable fault.The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the system logs and confirmed a single 23003 fault, pointing to a possible endoscope issue for serial number (b)(6).The customer could not get arm 2 to move, and the led was flashing yellow.The tse recommended to recover the fault.The customer performed this and was then able to move the arm.The surgeon elected to convert to an open procedure due to the patient.The tse suggested to rotate the endoscope shaft to see if any binding was present.The customer stated that the shaft rotated smoothly.The tse advised the customer to tag the endoscope, reprocess it, and return it if the issue returned.

Manufacturer Narrative

Based on the current information provided, the surgeon converted the procedure to open surgery due to the patient.There was no allegation of a malfunction of a da vinci product causing or contributing to the injury.

• Brand Name: NONE
• Type of Device: ENDOSCOPE
• 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: 18177947
• MDR Text Key: 328619245
• Report Number: 2955842-2023-20469
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/28/2023

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
• Device Operator: Health Professional
• Device Model Number: 470056
• Device Catalogue Number: 470056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2023
• Initial Date FDA Received: 11/20/2023
• 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