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

Model Number	478093-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical inc.(isi) received the 8mm fenestrated bipolar forceps instrument for failure analysis investigation.The instrument was analyzed and was found have a broken distal clevis at the base of the clevis.The broken piece was not returned, measuring roughly 0.2765¿ x 0.1870¿ in size.Clevis does not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis do not show damage.Additional findings not related to customer reported complaint: the instrument was found to have various scratches on the main tube.Scratches and abrasions on the main tube are deemed cosmetic damage.The scratches measured approximately 0.0810¿ - 0.01515¿ in length and are axially aligned with the tube axis.Components adjacent to this scratched main tube do not show damage.
Event or Problem Description
It was reported that during da vinci-assisted benign hysterectomy surgical procedure, the 8mm fenestrated bipolar forceps instrument tip plastic was found to be broken.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 customer noted there was breakage of the instrument when removing it from the trocar outside the patient's body with no report of fragments falling from the device while used within a patient.The patient did not return to the hospital due to experiencing any post-surgical complications related to retention of foreign material.

• Brand Name: SINGLE-SITE
• Common Device Name: FENESTRATED BIPOLAR 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: 20414206
• Report Number: 2955842-2024-20533
• Device Sequence Number: 15506262
• Product Code: NAY
• UDI-Device Identifier: 00886874113738
• UDI-Public: (01)00886874113738(17)251231(10)K12231207
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K130726
• 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
• Report Date (Section B): 09/23/2024

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: 478093-03
• Device Catalogue Number: 478093
• Device Lot Number: K12231207 0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Female