MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY; SYNCHROSEAL

Model Number 480440-05

Device Problem Fracture (1260)

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

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the synchroseal instrument involved with this complaint and completed the device evaluation.The reported event was unable to be reproduced during failure analysis investigation.The instrument was placed and driven on an in-house system and passed the recognition, engagement, and self-check tests.The instrument moved intuitively with full range of motion in all directions.The jaws opened and closed properly.Electrical continuity was tested and passed.The instrument was connected to the e-100 generator and was tested for energy delivery.The e-100 generator did not turn off during in-house testing and no intermittent sealing was observed.The grip force test was performed and passed specification.As part of investigation, additional unrelated findings were identified.Thermal damage on the cut electrode located on the bottom jaw of the grip set due to a component failure.The instrument had a torn jaw cover at the distal end.The tear measures 0.075" in length.No material appears to be missing.Root cause of this failure is attributed to mishandling/misuse.The instrument was further investigated by the isi advanced failure analysis engineer (afa).Afa engineer indicated that the e-100 generator shut down is related to a generator overcurrent protection during arcing events, not the instrument.Instrument investigation results indicated a cut electrode thermal damage, likely due to an arcing event.Markings on the inner lower jaw suggests that the arc remained within the instrument jaws.The issue is indicative of a component failure.Review of the e-100 generator logs identified seven cut electrode shorted errors, suggesting that arcing events occurred.Additionally, afa identified that one of the ceramic dots appeared to be broken, with burn marks indicating it was damaged during an arcing event and likely vaporized.The ceramic dot fragment was not returned with the instrument.A field service engineer (fse) was dispatched to the customer site and performed a proactive replacement of the e-100 generator.After replacement, the system was tested and verified as ready for use.Failure analysis of the e-100 generator with an in-house system found no functional issue.The e-100 generator was tested with an in-house synchroseal instrument.The instrument was energized and functioned properly for the sync activation as well as the cut and cautery functions.Instrument was tested multiple times and operated as expected.E-100 generator was operated for an extended period of time and functioned within specification.A review of the site's complaint history does not show additional complaints related to this product.A review of the instrument logs for the synchroseal instrument lot# l90210718 / sequence 0360 associated with this event has been performed.Per logs, the instrument was last used on the reported event date of (b)(6) 2021 on system (b)(4).The instrument is a single use instrument and no subsequent use recorded.No image or procedure video was provided for review.This complaint is considered a reportable event due to the following conclusion: failure analysis investigation acknowledges that a fragment was missing from a portion of the device that enters the patient (distal end); however, the site reported that no fragment fell into the patient.While there was no reported harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur as unintended fragment(s) falling into the patient may require surgical intervention.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy procedure, the e-100 generator connected to a synchroseal instrument powered off.The complaint alleges that the generator powered off therefore there is no energy delivered.There is no risk of any adverse event related to an unintended energy discharge to the patient.Troubleshooting was performed.The user continued the procedure with no further issue reported.No fragment fell into the patient.No known impact or patient consequence was reported.

• Brand Name: DA VINCI ENERGY
• Type of Device: SYNCHROSEAL
• 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: 13624622
• MDR Text Key: 296321360
• Report Number: 2955842-2022-10400
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(17)230731(10)L90210718
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480440-05
• Device Catalogue Number: 480440
• Device Lot Number: L90210718 0360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian