MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER EXTEND

Model Number 480422-01

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

4310 - intuitive has received the part associated with this complaint and completed investigations.Failure analysis investigations did not replicate or confirm the reported event.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with a full range of motion in all directions.The grips opened and closed properly.Energy was delivered without any issues, and the electrical continuity test passed.The jaw gap passed with the.003" gage.The instrument passed the ceramic dot verification test.The instrument passed the energy delivery test.A follow-up mdr will be submitted if additional information is received.Isi has reviewed the site¿s system logs.No related system errors were found to have occurred during the surgical procedure.This complaint is being reported due to the following conclusion: during use of the vessel sealer instrument, it was reported that the patient's tissue was not adequately sealed.While there was no patient harm, adverse outcome or injury reported, recurrence of the reported malfunction could cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted hemicolectomy surgical procedure, the vessel sealer extend instrument was not giving enough energy to seal correctly.The logs did not reflect any related information.The technical support engineer (tse) had the customer swap to another vessel sealer extend instrument; however, the issue persisted.The tse verified with the clinical sales representative (csr) that the surgeon was not grabbing too much tissue.The csr stated it had energy, but seemed like it was not enough to properly seal.The tse had the csr power cycle the erbe the generator, reseat the drapes; however, the issue persisted.The customer continued the procedure without completing all troubleshooting steps.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) clinical sales representative (csr) and the site's scrub tech was contacted and obtained the following information regarding the reported event.The first vessel sealer extend instrument worked as expected during the procedure for about an hour, but eventually started to have less power and did not emit as much energy as expected.As a result, there was mild bleeding observed.At that time, the surgeon clamped the vessel and applied pressure.The or staff removed the first vessel sealer extend and installed a second vessel sealer extend instrument.Once the second vessel sealer extend instrument was ported onto the system, this instrument also did not provide enough energy.However, the energy was sufficient enough to address the mild bleeding experienced by the patient.The csr confirmed that since the bleeding was minimal, there was no medical intervention rendered to the patient.It was confirmed that the site heard audible beeps from the system, indicating the sealing cycle was complete.However, there were no error codes generated.The following information was confirmed: the target tissue was not greater than 7mm, the patient had not undergone any chemotherapy or radiation treatment, and the vessel was not calcified.The instrument did not encounter any stapler or clips while attempting to seal.There was a little bit of bio debris on the jaws of the instrument.There is no video recording of the procedure.The other vessel sealer extend instrument referred in this will be reported in patient identifier: isi ref.(b)(4).

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 9533584
• MDR Text Key: 194343382
• Report Number: 2955842-2019-11009
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(17)210831(10)M91190812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2019

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: 480422-01
• Device Lot Number: M91190812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1