MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; BLACK DIAMOND MICRO FORCEPS

Model Number	420033-09
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis and the complaint was confirmed.The black diamond micro forceps instrument was analyzed and found to have a broken distal pitch cable at the proximal clevis hub.The broke cable segment that contains the crimp was still installed in the clevis.The cable was fully broken.There were no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.The components surrounding the broken cable did exhibit damage.Additional observation related to the reported complaint included: the instrument was found to have one of the pitch cables broken at the proximal end in the housing.The pitch cable was broken at the backend pulleys.The clamping pulley did not exhibit signs of corrosion/contamination/residue that would have contributed to the broken cable.The instrument also had a frayed grip cable at both the proximal clevis hole and the grip hub, but the cable was not fully broken.The frayed cable strands stuck out at the wrist.There were no cables to indicate a reprocessing induced issue.Further inspection found no abnormally sharp or damaged components that could have contributed to the cable breaking.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the surgeon felt that the black diamond micro forceps instrument was not working properly.On analysis, it was found instrument was not functioning properly.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 10-sep-2024: the failure was not related to unintuitive or uncontrolled motion.There was no movement at the instrument jaws.The issue did not occur with the surgeon¿s head inside the surgeon side console¿s (ssc's) high resolution stereo viewer (hrsv).The issue did not occur while the surgeon attempted to manipulate instruments from the ssc.The failure was related to an inability to move the instrument at all.There was no broken cable.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: BLACK DIAMOND MICRO FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20720107
• Report Number: 2955842-2024-22080
• Device Sequence Number: 19772335
• Product Code: NAY
• UDI-Device Identifier: 00886874111307
• UDI-Public: (01)00886874111307(10)N10170822
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/07/2024

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: 420033-09
• Device Catalogue Number: 420033
• Device Lot Number: N10170822 287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2017
• 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: Prefer Not To Disclose