MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CAMERA, 0°

Model Number	430060-41
Medical Device Problem Codes	Unintended System Motion (1430); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to starting, pre-anesthesia, a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure the sp camera instrument had the wire broken at the distal tip.The customer also reported that the camera twisted over to the right during one of the cases that day.The intuitive surgical, inc.(isi) technical service engineer advised reseating the camera and sterile adapter on the camera arm, but the issue persisted.Then, the isi tse suggested the issue could be related to the endoscope.The surgeon continued the procedures.The customer was planning to use another endoscope for the following case.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the nurse explained the camera was moving on its own without the surgeon controlling it.It may have been an camera issue once the camera shield was placed on it.The surgery was completed with the same camera with no harm or injury to the patient.The surgeon used the same camera from start to finish and there was no need to change it.The camera was in a sterile area/field thus it was hard for the nurses to pinpoint and figure out what was happening; they had their robot assist in trying to physically troubleshoot.Once it was cleared the same camera was used.The nurse was told the surgeon used the same camera on (b)(6) 2023 for a wire broken at the distal tip.She did not have a report of any broken distal tip on the camera.
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting the sp camera instrument had a wire broken at the distal tip, 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 camera instrument was analyzed and found to have a broken cable at the distal end.A review of recent logs is unavailable at this moment.A slight marking found on the camera head housing was done in-house and was not returned in that condition.The complaint regarding broken wire was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.Additional observations not reported by site: the camera was placed and driven on the in-house system and failed the qap (quality assurance procedure) during the intuitive motion test.The camera did not have a full range of motion, likely due to the broken drive cable.The instrument was found to have corrosion on one or more clamping pulleys in the backend.Upon visual inspection, there was a tear observed towards the proximal section of the camera cable.The tear measured about.076" in length.The camera cable exhibited silicone film on the contacts.The ferrule light guide connector exhibited heat damage.The root cause of a broken cable at the distal end is typically attributed to mishandling/misuse.The root cause of broken drive cable and corrosion is typically attributed to mishandling/misuse, most commonly caused by improper reprocessing techniques.The root cause of the tear on the proximal section of the camera is typically attributed to mishandling/misuse.This complaint is considered 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.At this time, the root cause of the failure is unknown.In addition, failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of 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: ENDOWRIST SP
• Common Device Name: CAMERA, 0°
• 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: 16659909
• Report Number: 2955842-2023-11680
• Device Sequence Number: 7274308
• Product Code: NAY
• UDI-Device Identifier: 00886874114384
• UDI-Public: (01)00886874114384
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 430060-41
• Device Catalogue Number: 430060
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Male