MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; VISION PROBE

Model Number 490206-01

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the claim against the product by the customer noting led sticking, 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 vision probe was analyzed and did not replicate nor confirm the customer reported complaint.Failure analysis found the primary finding of cannot verify external event to be related to the customer reported complaint.Upon visual inspection, there was no physical damage found at the distal tip and no moisture or liquid was observed in the cable adapter.No pin on the connector were found bent.The vision probe was installed on an in-house catheter and placed on the system.The led light was illuminated at the distal tip and an image was displayed on the monitor.No errors occurred during in-house testing.The vision probe was fully functional.There was no problem detected.Probe was reviewed with ion vision probe manufacturing engineer.Visual inspection of the fiber showed that 1 of the 2 illumination fibers was slightly protruding from the distal tip of the probe.An adhesive was observed on the sides and around fiber/camera in the tip; no cracks or holes were visible within the adhesive.Upon pushing against the fiber at the distal tip of the device, the fiber moved back inside during investigation but still was protruding slightly.The proximal end of the shaft was cut near the cable adapter and the fibers were pull up using tweezers.The fiber was not able to pulled proximally or pushed distally; the fiber remained protruding slightly and did not move during this manipulation.The vision probe was provided to ion vision probe design engineers and obtained the following additional information.Small pieces of adhesive were observed on the tip of the probe under magnification.Upon wiping the tip of the probe with a cotton tipped swab, adhesive particles were observed to be removed from the tip indicating that there is the potential for adhesive fragments at the distal tip of the device.The vision probe was inserted down an in-house catheter multiple times.The fiber was observed to piston in and out of the tip due to the vision probe compressing and stretching while going in and out of the catheter.Since the pistoling of the fiber was not observed during initial failure analysis, it is likely that the in-house testing and manipulation of the fibers from the proximal end led to further weakening of the adhesive around the fiber causing the fiber to come loose enough to move in and out of the distal tip of the device.Protruding fiber is likely due to inadequate primer or adhesive application during manufacturing.The root cause is attributed to manufacturing.The complaint regarding led sticking was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.No image or video was available for review.Verification of the event details cannot be performed via system logs because system logs do not exist (ion systems do not have onsite connectivity at this time).The probable root cause of the led sticking is attributed to manufacturing issue and is resolved by using alternate instrument.This complaint is reportable malfunction event due to 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 Description

It was reported that prior to the start of an ion endobronchial lung biopsy procedure, when the vision probe is attached, an led was sticking out of the end of the vision probe.The diagnostic procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: ION
• Type of Device: VISION PROBE
• 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: 16065292
• MDR Text Key: 308488521
• Report Number: 2955842-2022-16173
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/30/2022

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: 490206-01
• Device Catalogue Number: 490206
• Device Lot Number: S10220327 0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2022
• 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: ION ENDOLUMINAL SYSTEM