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

Model Number	420207-10
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the tenaculum forceps involved with this complaint and completed the device evaluation.Failure analysis investigation replicated/confirmed the reported complaint.The instrument¿s grip tips were not moving intuitively.Visual inspection was conducted and found the roll gear not in home position, causing the instrument to move incorrectly.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the tenaculum forceps instrument did not rotate properly.The procedure was completed with a replacement device and there was no report of patient injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: TENACULUM 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: 17067330
• Report Number: 2955842-2023-15729
• Device Sequence Number: 20365905
• Product Code: NAY
• UDI-Device Identifier: 00886874111659
• UDI-Public: (01)00886874111659(10)N10210208
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2021

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: 420207-10
• Device Catalogue Number: 420207
• Device Lot Number: N10210208 167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2021
• 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 Age: 33 YR
• Patient Sex: Female
• Patient Weight: 64 KG