MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; 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	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A return material authorization (rma) was issued to the customer requesting to have the intuitive device returned.However, isi has not received the product involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted radical hysterectomy surgical procedure, excessive play at the jaw point was detected during insertion.There was no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter; however, the initial reporter did not have further information to provide.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis (fa).The prograsp forceps instrument was analyzed, and the complaint was not confirmed by fa.The 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 damage or misaligned grip tips found.The instrument was fully functional.No product issue was identified.

• Brand Name: ENDOWRIST
• 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: 18067706
• Report Number: 2955842-2023-19910
• Device Sequence Number: 7684670
• Product Code: NAY
• UDI-Device Identifier: 00886874111345
• UDI-Public: (01)00886874111345(10)N10181026
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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: 420093-14
• Device Catalogue Number: 420093
• Device Lot Number: N10181026 088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2018
• 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: Female