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

Model Number	470405-06
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Isi has received the force bipolar instrument for investigation; however, failure analysis has not yet been completed.
Event or Problem Description
It was reported that during a da vinci-assisted transabdominal preperitoneal (tapp) umbilical hernia surgical procedure, the force bipolar instrument jaw was dislocated.The initial reporter indicated that the instrument did not have any problem on the cable or screw.The user completed the procedure using the backup instrument with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: the instrument was inspected prior to use.The instrument was grasping tissue and was not stuck in a closed position at the time of the issue.The instrument was removed normally.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.The reported event was confirmed through failure analysis investigation.The force bipolar instrument was tested by manipulating the grip disk input knobs and found a severely bent grip causing side to side/vertical misalignment of the grips.Inspection found a 0.084" offset at the tips.Further inspection found a dislodged molded insulator at the distal end, and this is related to the primary failure.Additionally, dried residue at the clamping pulley was also identified.The finding of dried residue is unrelated to both failures.

• 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: 17874165
• Report Number: 2955842-2023-18990
• Device Sequence Number: 15249599
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10200106
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K180351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: N10200106 0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 10/25/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown