MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; HANDHELD CAMERA HEAD

Model Number	470035-02
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The handheld camera instrument has been returned and evaluated by the failure analysis (fa) team.Failure analysis confirmed the customer's reported complaint.The camera connector was found to have a broken light guide cable adapter.The adapter cannot be properly seated on the connector and there are pieces missing.The root cause for the broken cable adapter is attributed to misuse.Additional observations(s) not reported by site include that the camera housing was found to have cosmetic damage.The laser markings were found to be partially removed and illegible.The root of this failure is attributed to misuse.Additionally, the camera cables were found to exhibit delamination at the housing.The root cause of the delamination is attributed to misuse.The camera was placed on the in-house system and failed the qap test (quality assurance procedure).A review of the error logs found no errors related to the camera.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or procedure video was provided for review.The lot # was not provided.Therefore, an instrument log review of the product related to the complaint cannot be performed at this time.This complaint is being reported based on the following conclusion: 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.
Event or Problem Description
It was reported that after a da vinci-assisted bilateral inguinal hernia repair surgical procedure, the handheld camera light cord tube was broken.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 customer reported that the procedure performed was an inguinal hernia repair on (b)(6) 2022.The instrument was inspected prior to use and there were no issues noted.No image or procedure video was available for review.
Additional Manufacturer Narrative
The failure analysis for the handheld camera was further reviewed and it was noted that the broken piece was from the light guide adapter which plugs into the third party endoscope.The handheld camera cable adapter is not a component that could fall inside the patient's body.It is located at the connector of the cable and plugs into the endoscope controller; therefore, the part does not come in contact with the patient.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: HANDHELD CAMERA HEAD
• 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: 14520318
• Report Number: 2955842-2022-11827
• Device Sequence Number: 14854082
• Product Code: GCJ
• UDI-Device Identifier: 00886874115725
• UDI-Public: (01)00886874115725
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 470035-02
• Device Catalogue Number: 470035
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 07/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 61 YR
• Patient Sex: Male