MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; DEBAKEY FORCEPS

Model Number	470036-04
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the debakey forceps instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.An image associated with this reported event was submitted for review.Review of the provided image shows a frayed cable partially sticking out at the jaws while the instrument jaws are bent at a 90-degree angle.
Event or Problem Description
It was reported that during a da vinci-assisted revascularization of the myocardium surgical procedure, the debakey forceps instrument released a filament from the steel cable at its tip joint, on its second use, leaving 8 lives left.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information: the instrument was inspected prior to use and no damage or anything out of the ordinary was found before the procedure.The surgical task was completing the surgery, myocardial revascularization surgery.The instrument did not collide with any other instrument or tool.There were no issues opening/closing the grips, left/right (yaw) motion, or up/down (pitch) motion.One cable was visibly protruding from the distal end, a photo was previously sent.The customer could not answer which motion the protruding cable controls.One micro filament broke but did not release from the tweezers.A fragment did not fall into the patient.The instrument was available for return and was already sent last week.An image was attached.
Additional Manufacturer Narrative
The debakey forceps instrument has been returned and evaluated by the failure analysis team.Failure analysis investigations replicated/confirmed the customer reported complaint.The instrument was found to have a frayed pitch cable at the clevis hub.Some bundles of the cable were frayed, but the cable is not fully broken.The frayed cable strands stuck out at the wrist.There was no evidence of discoloration or corrosion/contamination on the cables to indicate reprocessing induced issue.The components surrounding the frayed cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable fraying.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: DEBAKEY 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: 19227332
• Report Number: 2955842-2024-14165
• Device Sequence Number: 15174293
• Product Code: NAY
• UDI-Device Identifier: 00886874112236
• UDI-Public: (01)00886874112236(10)N10200317
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K150284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: 470036-04
• Device Catalogue Number: 470036
• Device Lot Number: N10200317 0020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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