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

Model Number	420093-14
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the prograsp forceps instrument did not move the way the surgeon wanted it.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-ups attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Based on the claim against the product by the customer, an investigation is in progress to determine the cause of this reported event.Intuitive surgical, inc.(isi) has not received the da vinci product with an alleged issue to perform failure analysis as it is pending return.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The prograsp forceps instrument was analyzed and reported failure was confirmed.The instrument was found to have an imprecise motion failure.This instrument¿s grip tip was not moving intuitively, i.E.It was not following the master tool manipulator (mtm) input commands smoothly.The instrument tip did not move intuitively at the pitch orientation.The instrument exhibited imprecise motion.The root cause is attributed to a loose pitch cable.Additional observation related to the customer reported complaint: 1.The instrument was found to have a loose pitch cable at the proximal end.As a result, the instrument exhibited an imprecise motion.The pitch input was manually articulated, and it was found to be loose.The instrument housing was opened, and the pitch cable was found to be loose from its groove.No cracking of clamping pulley was observed.The screws securing the clamping pulleys were tight.The complaint was confirmed by failure analysis, which indicates that the device contributed to the customer reported issue.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
The prograsp forceps instrument was transferred to the engineering team and initial findings were confirmed.The prograsp forceps did have a loose pitch cable on the distal and proximal end.It was confirmed that there was no damage to the clamping pulleys and the screws securing the clamping pulley were tight.As no damage was observed to the clamping pulley and screws, it is likely that the pitch cable experienced a loss of tension over time and use, resulting in the loose cable.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 17532045
• Report Number: 2955842-2023-17693
• Device Sequence Number: 6102056
• Product Code: NAY
• UDI-Device Identifier: 00886874111345
• UDI-Public: (01)00886874111345(10)K10221201
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2023

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: 420093-14
• Device Catalogue Number: 420093
• Device Lot Number: K10221201 077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/15/2023; 10/03/2023
• Initial Report FDA Received Date: 08/12/2023
• Supplement Report FDA Received Date: 08/31/2023; 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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