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

Model Number	410322-05
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the vessel sealer (vs) instrument involved with this complaint and completed the device evaluation.Failure analysis could not replicate nor confirm the reported complaint.No visible damage was observed at the wrist.The electrical continuity test passed.The instrument was placed and driven on an in-house system.The instrument passed the initialization tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The knife cut cleanly through test strip paper.The knife edges were not damaged.Cut test passed.Energy activation test was then conducted on system.Wet paper towel was held between grips and began to smoke when energy pedal was pressed.Steam generation from the towel indicated active power and a complete circuit.The instrument was ready for use.
Event or Problem Description
It was reported that during a da vinci-assisted total benign hysterectomy surgical procedure, the customer noted the vessel sealer (vs) instrument stopped working and was not recognized by the system.The vs worked for the beginning of the case then stopped working.The customer informed the instrument was not removed prior to it having the function error.There was no reported injury or harm.Intuitive surgical, inc.(isi) followed up with the robotic coordinator and obtained the following additional information: the customer confirmed they opened two different vessel sealer (vs) that did not work, then lost power on the surgeon side console (ssc), and the surgeon opted to convert to laparoscopic procedure.It was noted that the erbe integrated electrosurgical unit (iesu) generator was not recognizing the instrument after previously working fine.The nurse did not perform troubleshooting with technical support as they were called after the case.The customer informed that the system was inspected prior to use and no issues were noted during the system setup.It was noted the procedure was in progress about 45 to 50 minutes when the issue occurred.The customer attempted to reseat the instrument.The customer stated the surgeon believed the cause of the reported event was due to the vs instruments and iesu malfunction.Both vs instruments were inspected prior to use, and nothing out of the ordinary was observed.At the time of the instrument use, the surgeon was attempting to seal and cut the uterine suspension tissue; however, the iesu intermittently stated the instrument was not recognized.The customer noted that the vs instrument worked as normal for the beginning of the case.Intermittent errors would flash on the iesu machine and then would disappear.It was confirmed that during the sealing sequence an audible signal was heard when the pedal was pressed, and fast audible tones were heard indicating the seal cycle was complete.The target tissue according to the customer was under tension during the sealing/cutting process, and the vessel was not greater than 7mm in diameter.No vessel calcification was observed nor had the tissue been exposed to any radiation or chemotherapy.Tissue effect was observed during the sealing cycle.Additionally, both vs instrument did not have contact with any staples, clips, or other material objects, nor were the instrument jaws immersed in a liquid or contaminated by carbonization.No unexpected bleeding was noted and no post-operative complications were experienced.Both vs instrument will be returning for analysis.No video/image was available for review.The customer confirmed the procedure was completed laparoscopically with no patient injury or harm.This medical device report is being submitted to capture the second vessel sealer instrument malfunction reported by the customer.Patient identifier (b)(6) captures the first vessel sealer instrument.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: VESSEL SEALER
• 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: 17067414
• Report Number: 2955842-2023-15756
• Device Sequence Number: 6775535
• Product Code: NAY
• UDI-Device Identifier: 10886874111113
• UDI-Public: (01)10886874111113(10)M10191022
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K110639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: 410322-05
• Device Catalogue Number: 410322
• Device Lot Number: M10191022 284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White