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

Model Number	430009-57
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci assisted cholecystectomy procedure, the patient experienced bleeding that required surgical intervention.While the cadiere forceps instrument retracting the gallbladder was noted to have a broken wire, the surgeon noted that the bleeding was anticipated and reported as negligible.The bleeding was resolved by using a maryland bipolar forceps instrument for cauterization; transfusion of blood products was not required.The surgeon stated that the event was not caused by a malfunction of a da vinci system, instrument, or accessory.
Additional Manufacturer Narrative
Based on the information provided, the cause of the customer reported complication cannot be determined although the surgeon believes the bleeding was anticipated, and unrelated to a malfunction of a da vinci system, instrument, or accessory.Intuitive surgical, inc.(isi) did receive the 6mm cadiere forceps instrument to perform failure analysis (fa) investigations.The instrument was found to have a dislodged cable crimp at the constraint wrist and joggle cable 9.The instrument cable crimps at the end of the wrist cables, tend to slip, causing the cable to appear broken.A review of the provided image revealed the following additional information: the instrument was confirmed as an sp cadiere forceps with a dislodged cable crimp protruding from the instrument shaft.

• Brand Name: ENDOWRIST SP
• Common Device Name: CADIERE 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: 20042093
• Report Number: 2955842-2024-18385
• Device Sequence Number: 7933751
• Product Code: NAY
• UDI-Device Identifier: 00886874115213
• UDI-Public: (01)00886874115213(11)231109(10)K11231109
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• 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
• Report Date (Section B): 07/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 430009-57
• Device Catalogue Number: 430009
• Device Lot Number: K11231109 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose