MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FORCE BIPOLAR

Model Number 471405-06

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/16/2021

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted ventral hernia surgical procedure, the force bipolar instrument gage pin on the jaws became loose and the hernia sac was caught in the jaws.Before taking out the instrument, the pin fell out into the patient.The pin was retrieved successfully with no harm to the patient.The instrument would not come out to the cannula and the staff had to ¿burp¿ the trocar out of the patient.The staff used a spare instrument and proceeded with the case.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the isi clinical sales representative (csr) and obtained the following additional information: while the surgeon was getting ready for his next surgical task, a protruding piece was noticed on the instrument.The surgeon touched the piece with another instrument and it fell inside of the patient.It is unknown if any tests or x-rays were performed.The surgeon does not know what caused the instrument to break.The instrument was inspected prior to use.The instrument did not collide with any other instruments or hard materials.The instrument was not removed from the patient prior to the breakage.There was no harm to the patient.The fragment was removed during the same procedure.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the force bipolar instrument be returned for failure analysis to be performed, but the instrument 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.A review of the site's complaint history does not show any additional complaints related to this product.No image or video clip for the reported event was submitted for review.A review of instrument log was performed.The instrument was last used on (b)(6) 2021 on system (b)(4) for 14 minutes.Force bipolar instrument has 5 uses remaining after last use.The instrument has maximum 12 uses.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the force bipolar instrument pin on the jaws became loose and fell into the patient.The fragment was retrieved during the same procedure with no patient injury.At this time it is unknown what caused the breakage to occur.While there was no 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

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1 b1 updated from "product problem" to "adverse event and product problem".B2 updated to "required intervention".H1 updated from "malfunction" to "serious injury".

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• 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: 12965136
• MDR Text Key: 287008746
• Report Number: 2955842-2021-11698
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)N10200914
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180351
• 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,Followup
• Report Date: 11/16/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: N10200914 0091
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 11/16/2021
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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.