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

Model Number	470405-06
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the force bipolar (fb) instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation did not replicate nor confirm the customer reported complaint.Upon visual and microscopic inspection, no damage was found to the cable assembly.No broken or frayed cable was observed.The customer also reported a complaint of "would not grip." this complaint was confirmed.The instrument was found to have a severely bent grip, and the tip did not align with the other grip.
Event or Problem Description
It was reported that during a da vinci-assisted incisional hernia repair surgical procedure, the force bipolar (fb) instrument would not release the tissue while surgeon was at the console.The customer attempted to use the emergency release kit; but, it did not work.Therefore, the surgeon cut the piece of tissue that was attached to the instrument in order to remove the instrument from the patient.Intuitive surgical, inc.(isi) follow-up with the customer site and received the following information from the robotic lead: the fb instrument malfunctioned during the case; the jaws would not open.Before the case, the instrument was inspected and nothing was noticed.There was no intra-operative complications other than getting another instrument which took only a few minutes.The tissue that was taken out with the instrument was peritoneum which was being dissected at the time.It was confirmed that the surgeon did not have to suture the area, it was just a very small piece of tissue.It is unknown if the instrument was in strong grip mode and if the patient had any port-operative complications.The procedure was completed as planned with a backup fb instrument.

• Brand Name: ENDOWRIST
• Common Device Name: 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: 17093841
• Report Number: 2955842-2023-16096
• Device Sequence Number: 1931936
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10200106
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K180351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: N10200106 0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White