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

Model Number 470056-05

Device Problem Image Orientation Incorrect (1305)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the claim against the product by the customer noting non-intuitive motion, an investigation is completed to determine the cause of this reported event.The reported event was addressed with phone support.The customer switched to spare endoscope to resolve the reported issue.No site visit was conducted.The system was working properly and no additional action was required as the issue was resolved.This complaint is considered 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 radical extraperitoneal prostatectomy with lymphadenectomy surgical procedure, the 0 degree endoscope rotation did not match with the horizon line.The surgeon could not rotate the endoscope and the instrument's movements were not intuitive anymore.Intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the error logs and there were no engagement errors on the universal surgical manipulator (usm) 2.The tse guided the customer to remove the endoscope and verify whether they could hear a grinding noise when rotating the endoscope manually, which was the case.The tse recommended the customer to replace the affected endoscope with a spare one and the customer continued with the procedure as planned with no further issues.The tse had advised to return the endoscope for isi evaluation.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the tse and obtained the following additional information: the tse was able to clarify that the image was not completely inverted and that the system's arm control was also not completely reversed.There was no report of the endoscope moving freely with uncontrolled motion, so it most likely did not occur.The tse assumed that the surgeon confirmed the desired orientation when endoscope was installed, since this event occurred mid-procedure.An indication of the image orientation was provided to the user via user interface, as the horizon line shown on the vision side cart (vsc) did not match with the endoscope physical rotation showing a mismatch of less than 180 degrees.There were no engagement errors shown, so it seems the endoscope and endoscope¿s adapter was still engaged, in-synch, and attached properly.There was no damage reported by the customer but they reported a reproduced grinding noise when rotating the endoscope manually.The customer did not manually rotate the endoscope 180 degrees.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The 0 degree endoscope was analyzed and found to have a friction issue and a damaged endoscope adaptor (aea).The instrument was also found with a damaged and cracked sapphire distal window, mechanical damage on the shaft, damaged laser markings on housing, visual cable integrity damage, a cracked window distal, and discoloration of the housing.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 16671745
• MDR Text Key: 312868646
• Report Number: 2955842-2023-11732
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874116562
• UDI-Public: (01)00886874116562
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K191736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470056-05
• Device Catalogue Number: 470056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• 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
• Patient Sex: Male