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 02/07/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the claim against the product by the customer noting the image orientation issue, an investigation is in progress to determine the cause of this reported event.A return material authorization (rma) was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Isi has not received the product involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted if the product is returned (post failure analysis evaluation) or if additional information is received.The investigation to determine the cause of this reported event is currently in progress.As such, the probable root cause cannot yet be determined based on the information provided.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: it was alleged that the endoscope moved with unintuitive motion.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 partial nephrectomy surgical procedure, the customer stated that the image produced by the endoscope was mirrored causing instruments incorrect movements.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 the date of this report.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the 0-degree endoscope unit involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.The camera instrument adapter was noted to be damaged or friction issue.Additionally, an artifact was noted on the right eye.The complaint regarding the ¿image produced by endoscope was mirrored causing instruments incorrect movements¿ was confirmed by failure analysis, which indicated that the device did contribute to the customer reported issue.

• 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: 16702724
• MDR Text Key: 312912941
• Report Number: 2955842-2023-11840
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K191736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2021
• 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