MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CADIERE FORCEPS

Model Number	478055-04
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted hysterectomy surgical procedure that the cadiere forceps instrument broke, while grasping tissue.The fragments were retrieved through the patient's vagina.There was no reported injury.Intuitive followed up with the initial reporter and the following additional information was obtained: the instrument was inspected prior to use.No damage, nor anything out of the ordinary, was found.When the device fragment fell inside the patient, the trainee was trying instrument to move it.The surgeon believed that excessive force in moving the instrument caused the instrument to break.The instrument was in use for 1.5 hours before the issue occurred.No issues were found with the functionality of the instrument during the surgical procedure.It is believed that the instrument collided with a monopolar curved scissors instrument during the surgical procedure.The instrument was not removed during the procedure (prior to the breakage).The surgical staff did not feel any resistance upon removal of the instrument through the cannula.It is unknown if the wrist was straightened upon final removal of the instrument.No damage was found to the cannula.No other damage was found to the instrument.The fragments were retrieved and delivered through the patient's vagina.When the instrument broke, the site identified that there were x3 fragments, and x3 fragments were retrieved.An additional surgical procedure was not required to remove the fragment.No post-operative tests, like an x-ray or ultrasound, were performed to check for remaining fragments.The procedure was completed robotically.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The cadiere forceps instrument was analyzed and found to the complaint regarding the instrument breaking was confirmed by failure analysis.The instrument was found to have an ear of the distal clevis broken.The broken piece, measuring 0.189¿ x 0.327¿, was not returned.The grip tips were found to be dislodged as well.The complaint regarding the fragment falling was confirmed by failure analysis.A review of the provided image was consistent with the alleged complaint of the instrument breaking.

• Brand Name: SINGLE-SITE
• Common Device Name: CADIERE 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: 18038481
• Report Number: 2955842-2023-19804
• Device Sequence Number: 18025188
• Product Code: NAY
• UDI-Device Identifier: 00886874113608
• UDI-Public: (01)00886874113608(10)K10230124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 478055-04
• Device Catalogue Number: 478055
• Device Lot Number: K10230124 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American