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

Model Number 470056-08

Device Problem Image Orientation Incorrect (1305)

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

Event Date 03/17/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the claim against the product by the customer noting image upside down, an investigation was completed to determine the cause of this reported event.The reported event was addressed with phone support.The customer reseated the endoscope, and the movement was normal.No site visit was conducted.The system was working properly, and no additional action was required as the issue was resolved.This complaint is reportable malfunction event due to the following conclusion: it was alleged that the endoscope had opposite movement.Poor camera control could result in unintuitive motion and subsequent tissue damage.At this time, the root cause of the failure is unknown.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported that during a da vinci-assisted oophorectomy surgical procedure, the image was upside down and the instruments moved opposite.The issue was opposite movement on both instruments, the customer reseated the endoscope and then movement was normal.The customer proceeded with the case and would test the endoscope shaft roll at end of procedure and return as needed.The procedure was completed with no reported 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: 16717367
• MDR Text Key: 313072173
• Report Number: 2955842-2023-11884
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470056-08
• Device Catalogue Number: 470056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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