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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cadiere forceps involved with this complaint and completed the device evaluation.Failure analysis investigation replicated and confirmed the customer reported complaint.Failure analysis found the primary failure of broken clevis to be related to the customer reported complaint.The instrument was found to have an ear of the distal clevis broken.The broken piece was returned, measuring roughly 0.189¿ x 0.342¿ in size.As a result of the broken clevis, the clevis pin was found to be dislodged.The clevis pin was returned.The root cause of these failures are typically attributed to the misuse/mishandling.Additionally, one of the grip tips was also found to be dislodged due to the broken clevis and the grip tip was returned.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the cadiere forceps broke and had fragments fell inside the patient.The customer retrieved the fragments after undocking.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the fragments were retrieved during the same procedure and the customer was able to match it with the instrument.No additional surgical procedure or post-operative tests like an x-ray or ultra sound were required to check for remaining fragments.The instrument was in use for 20-30 minutes.The instrument was inspected prior to use and there wasn't anything out of the ordinary.The surgeon was grasping tissue when the device fragment fell inside the patient.The surgeon did not notice any issues with the functionality of the instrument during the surgical procedure.The instrument did not collide with any other instruments or other hard material during the surgical procedure.The instrument did not collide with any other instruments or other hard material during the surgical procedure.The instrument was removed prior to the breakage with the wrist straightened prior to removal.The surgical staff did not feel any resistance upon removal of the instrument through the cannula.Upon final removal of the instrument, the wrist was straightened and there was no resistance through the cannula.The surgical staff did not notice any damage or any other damage on the instrument after the event occurred.There was no injury to the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.

• 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: 16928159
• Report Number: 2955842-2023-13578
• Device Sequence Number: 6720044
• Product Code: NAY
• UDI-Device Identifier: 00886874113608
• UDI-Public: (01)00886874113608(10)N10200302
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2021

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: N10200302 0011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2020
• 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: Unknown