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	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A return material authorization (rma) was issued to the customer requesting to have the intuitive device returned.However, isi has not received the product involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted if the product is returned (post failure analysis evaluation) or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the 8mm debakey forceps instrument wrist cable broke.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.There was no damage or anything out of the ordinary observed.The issue occurred during a mitral valve repair.The instrument did not collide with any other instrument or tool during the procedure.There were no issues related to opening or closing the grips, to left and right (yaw) motion of the grips or up and down (pitch) motion of the wrist.One cable, which is controlling the opening and closing of the jaws, was visibly protruding from the distal end of the instrument.No fragment fall inside the patient's anatomy.No video or photographic images of the devices are available of is review.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 8mm debakey forceps instrument for failure analysis investigation.The instrument was analyzed and was found to have a frayed grip cable at the idler pulleys.Some wires were broken, but the cable itself was not fully broken.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.Additional observation not reported by site: the instrument was found to have multiple indentations on the edge of the distal idler pulleys.There were no pieces missing.

• 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: 19957005
• Report Number: 2955842-2024-18099
• Device Sequence Number: 21057158
• Product Code: NAY
• UDI-Device Identifier: 00886874112236
• UDI-Public: (01)00886874112236(10)N10200713
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: N10200713 0021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 08/10/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2020
• 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