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

Model Number 470035-02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/27/2023

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, it is unknown when or why the surgeon made the decision to abort the procedure to open surgery.There was no allegation that a malfunction of a da vinci product caused or contributed to the injury.Intuitive surgical, inc.(isi) has not received the handheld camera head for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned (post-failure analysis evaluation) or if additional information is received.

Event Description

It was reported that prior to starting a da vinci-assisted surgical procedure, the handheld camera head image was distorted.The procedure was aborted to an open surgery.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information, however, no further details were provided.

Manufacturer Narrative

On 15-aug-2023, the following additional information was obtained: there was zero information from the customer on when/what case the damage happened to the camera.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive the handheld camera head to perform failure analysis (fa).Fa did not confirm/reproduce the customer reported complaint.The camera was placed on the in-house system and passed the quality assurance procedure (qap) test.Image was focused and light output was normal.The system logs showed no errors.Additional observations not reported by site that are not related to the customer reported complaint: fa found the camera to have illegible laser markings on the housing and a delaminated bend protection of the cable where it meets the housing of the camera.Fa found the camera to have cracked and broken corners on the hand grip of the integrated connector.The hand grip was not dislodged from the integrated connector.Fa also found the camera to have a dent on the focus ring.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: NONE
• Type of Device: 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: 17638037
• MDR Text Key: 322134291
• Report Number: 2955842-2023-18044
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00886874115725
• UDI-Public: (01)00886874115725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 08/15/2023; 11/13/2023
• Supplement Dates FDA Received: 09/08/2023; 11/29/2023
• 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