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

Model Number	478080-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The bipolar maryland instrument was analyzed and found to have a broken proximal clevis at the ears of the clevis.Some of the broken pieces were not returned, measuring roughly 0.167¿ x 0.152¿ in sizes.The clevis does not show abrasions or scratches on the outer surface.Components adjacent to the broken clevis show damage which may indicate potential mishandling/misuse.Both grip and pitch cables are derailed.The complaint regarding the wrist of the device being broken was confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, user observed that the wrist part of the bipolar maryland instrument was broken while they were suturing tissue.The instrument was removed and replaced with a backup.Following this, the user continued and completed the procedure with no further issues.No fragment fell into the patient.A procedure delay of 15 minutes was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the reporter confirmed that the wrist part was not detached from the shaft and no fragment fell into the patient.There was no patient injury.The instrument did not collide with any other instruments or other hard materials during the surgical procedure.The reporter did not know the instrument's batch sequence number.The reporter was unable to disclose the patient demographic information.

• Brand Name: SINGLE-SITE
• Common Device Name: BIPOLAR MARYLAND
• 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: 20793839
• Report Number: 2955842-2024-22524
• Device Sequence Number: 7980464
• Product Code: NAY
• UDI-Device Identifier: 00886874113707
• UDI-Public: (01)00886874113707(17)251231(10)K10231218
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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: 478080-03
• Device Catalogue Number: 478080
• Device Lot Number: 0049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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: Prefer Not To Disclose