MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PROGRASP FORCEPS

Model Number	420093-12
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, after the kidney was unclamped and the beginning of the reconstruction was occurring; repeated recoverable 48100 faults occurred.The fault remained even after troubleshooting with dvstat and rebooting the system and completing a hard cycle power.Since the needle driver instrument was holding a needle the instrument release kit (irk) was used to safely remove it which is why the instrument is being returned.The surgeon made the decision to convert the procedure to traditional laparoscopic techniques with no reported injury.The prograsp forceps instruments are multiple-use endoscopic instruments with a grasping tip to be used in conjunction with the da vinci system.The instrument is designed to grab, manipulate, retract, and dissect tissue during a da vinci assisted surgical procedure.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the prograsp forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation did not replicate nor confirm the customer reported complaint of encountered robot faults.The prograsp forceps instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.No errors appeared.There was no problem detected.The instrument was fully functional.Additional observation not reported by the site was that the instrument was found to have a frayed grip cable at the distal for amp pulley.The frayed cable strands stuck out at the wrist.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PROGRASP FORCEPS
• 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: 17067484
• Report Number: 2955842-2023-15802
• Device Sequence Number: 6688570
• Product Code: NAY
• UDI-Device Identifier: 00886874111345
• UDI-Public: (01)00886874111345(10)N10180103
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 420093-12
• Device Catalogue Number: 420093
• Device Lot Number: N10180103 031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2017
• 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 Sex: Unknown