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

Model Number	470405-06
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed nor replicated.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests and it moved intuitively with full range of motion in all directions.The grips opened and closed properly.No grip misalignment was observed.Visual inspection was performed and found no damages.No sharp edges were observed.The root cause is no problem detected.
Event or Problem Description
On (b)(6) 2021, intuitive surgical, inc.(isi) received [user facility report 2301650000-2020-8010] stating: a middle aged female patient who presented for elective robotic-assisted repair of incarcerated incisional hernia.Had a history of three previous hernia repairs.Her bmi was 38 and her medical history was significant for smoking, hypertension, and diabetes mellitus.During her surgery, staff were unable to open one jaws of the 8mm force bipolar instrument.The instrument was being used in conjunction with the da vinci xi robot and had 6 uses left.The instrument had been grasping tissue at the time of malfunction.Staff attempted to open the jaws using an emergency wrench but were unsuccessful.They called customer service but were still unable to remedy the situation.The surgeon had to cut surrounding tissues to free the instrument for removal.However, staff were also unable to straighten the instrument so that it could be removed through the trocar.The surgeon had to extend the port incision to facilitate removing the trocar and instrument as a unit.The patient tolerated the procedure well and was discharged home the following day.

• 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: 17093840
• Report Number: 2955842-2023-16095
• Device Sequence Number: 13936028
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10191125
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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: N10191125 0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2019
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White