MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, 4-ARM

Model Number 380614-09

Device Problem Crack (1135)

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

Event Date 03/18/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the camera head be returned for evaluation, but it has not yet been received.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.The batch lot number was incomplete.Therefore, an instrument log review of the product related to the complaint cannot be performed at this time.A review of the site's complaint history identified no other complaints related to the instrument and/or this event.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: the customer converted to laparoscopy after the start of the procedure due to a broken camera head.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

Event Description

It was reported that during a da vinci assisted partial nephrectomy surgical procedure, the fixation of the camera head was found broken.The procedure was converted to laparoscopic surgery.There was no report of patient injury.Per subsequent follow-up, the customer confirmed the endoscope broke at the beginning of the surgery.Since no backup endoscope was available, the surgeon decided to proceed laparoscopically.There was no consequence for the patient.The hospital declined to provide patient information.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the toshiba camera head involved with this complaint and completed the device evaluation.Failure analysis (fa) confirmed but not replicated the customer reported complaint.The camera head coupler was found broken.The light cable was damaged and needed to be replaced.The camera head was found to have the damaged housing components due to the mechanical shock which needed to be replaced and relabeled.The root cause of this failure is attributed to mishandling/misuse.

• Brand Name: DAVINCI SI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: 14132566
• MDR Text Key: 291316085
• Report Number: 2955842-2022-11122
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

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
• Device Operator: Health Professional
• Device Model Number: 380614-09
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2012
• 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.