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

Model Number	420093-14
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Although the complaint was not confirmed by failure analysis since the instrument was not returned, the information gathered indicates that the device may have contributed to the customer reported issue.A review of the submitted image was performed by an intuitive surgical, inc.(isi) regulatory post market surveillance (rpms) analyst.The following additional information was provided: the image shows the instrument with a protruded tip and product information.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the user observed that a pin on the prograsp forceps instrument was protruded.The user further noted that the instrument was difficult to remove.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.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the prograsp forceps instrument involved with this complaint and completed the device evaluation.The reported event was confirmed through failure analysis investigation.Inspection identified the grip pin dislodged at the distal end.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.The instrument passed the bumper and gripping test with no issue.The instrument was retested and passed testing on all attempts.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
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 and no problems were found before surgery.The instrument grip/clevis/pivot pin was not dislodged/missing/loose.No incidence of collision with other instruments or tools confirmed.No fragment fell inside the patient.After the surgeon carefully straightened the wrist joint, the nurse slowly pulled it out with obvious resistance.
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: 18244176
• Report Number: 2955842-2023-20801
• Device Sequence Number: 20475873
• Product Code: NAY
• UDI-Device Identifier: 00886874111345
• UDI-Public: (01)00886874111345(10)K10221117
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2023

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: K10221117 448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 01/17/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/23/2023; 02/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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