MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; SMALL CLIP APPLIER

Model Number	420003-09
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the small clip applier instrument was unable to properly clamp.The procedure was completed using a backup instrument with no further issue reported.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the small clip applier instrument involved with this complaint and completed the device evaluation.The instrument was tested with an in-house system and passed recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The instrument was further tested and failed the grip clip test.Visual inspection identified no signs of obvious damage on any cable or wires, and all other parts of the instrument.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: SMALL CLIP APPLIER
• 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: 17015838
• Report Number: 2955842-2023-14963
• Device Sequence Number: 7668828
• Product Code: NAY
• UDI-Device Identifier: 00886874111161
• UDI-Public: (01)00886874111161(10)N10191209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 06/26/2020

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: 420003-09
• Device Catalogue Number: 420003
• Device Lot Number: N10191209 346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2019
• 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