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

Model Number	420207-10
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the tenaculum forceps instrument was found to have a broken cable.The procedure was completed with a backup instrument of same kind.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use, and no damage was found.The customer indicated that a strand of cable was found protruding from the distal end of the instrument.The instrument did not collide with any other instrument or tool during the procedure.There was no report of fragment(s) falling inside the patient.
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the tenaculum forceps instrument.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.A review of the provided image was performed by an intuitive surgical, inc.(isi) failure analysis engineer.The following additional information was provided: it looks like there is a broken pitch cable.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The tenaculum forceps instrument was analyzed and found to have a broken pitch cable at the distal end.The broken cable segment that contains the crimp was still installed in the clevis.The complaint regarding broken cable was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.

• 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: 18433184
• Report Number: 2955842-2023-21906
• Device Sequence Number: 7092458
• Product Code: NAY
• UDI-Device Identifier: 00886874111659
• UDI-Public: (01)00886874111659(11)230209(10)K11230209
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: 420207-10
• Device Catalogue Number: 420207
• Device Lot Number: K11230209 936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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: 29 YR
• Patient Sex: Female