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

Model Number 470057-05

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

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

Event Date 02/06/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, there was a shuffling sound from the 30-degree endoscope housing, and the buttons were difficult to press.The customer used a backup endoscope to continue the procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the 30-degree endoscope was inspected prior to use with no issue.The customer heard a squealing sound in the endoscope housing, and it was difficult to press the endoscope buttons.There was no inverted image.The endoscope did not move freely with uncontrolled motion.There was no patient injury.

Manufacturer Narrative

Based on the claim against the product by the customer noting that there was a shuffling sound from the endoscope housing and endoscope buttons were difficult to press, 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 30-degree endoscope was analyzed and found that the desiccant balls were dislodged in the camera housing.The probable root cause of the reported failure was attributed to a component failure.Failure analysis found an additional observation related to the reported complaint: the camera buttons failed the functional tests.The probable root cause was not determined.Failure analysis also found additional observations, which were not related to the reported complaint: the endoscope cable was damaged.The probable root cause of this failure was typically attributed to damage during use.The endoscope adapter (aea) was damaged.The aea retraining ring was dislodged.One of the screws on the aea gear was missing.The probable root cause of this failure was attributed to manufacturing.The complaint regarding the sound and hard buttons were confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: the xi endoscope was found with a dislodged camera instrument adapter (aea) component.A dislodged camera adapter and/or missing retaining ring results in poor camera control, which 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.

• 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: 16657674
• MDR Text Key: 313075325
• Report Number: 2955842-2023-11671
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116555
• UDI-Public: (01)00886874116555
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470057-05
• Device Catalogue Number: 470057
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2023
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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