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

Model Number 470057-08

Device Problems Unintended System Motion (1430); Physical Resistance/Sticking (4012)

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the claim against the product by the customer noting endoscope would not turn an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The endoscope was analyzed and found to have the attached endoscope adapter (aea) damaged of friction issue.The endoscope also had button mechanical damage, discoloration of housing, strain relief on ic housing, and corrosion or physical damage to ic emi fingers.The complaint regarding endoscope would not turn was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.This complaint is being classified as a reportable event due to the following conclusion: it was alleged that the endoscope moved freely with uncontrolled motions.Poor camera control could result in unintuitive motion and subsequent tissue damage.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 proctectomy surgical procedure, the endoscope would not turn into position and would not stay in place.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.

• Brand Name: NONE
• Type of Device: ENDOSCOPE PLUS
• 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: 16215008
• MDR Text Key: 308946889
• Report Number: 2955842-2023-10202
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• UDI-Public: (01)00886874116555
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K191736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470057-08
• Device Catalogue Number: 470057
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2023
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2021
• 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: Male