MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; CANNULA, STANDARD, REUSABLE

Model Number	470002-08
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted abdominoperineal resection (apr) surgical procedure, the fenestrated bipolar forceps instrument broke at the tip and could not be removed by the trocar so the trocar, along with the instrument had to be removed from the patient.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive received the cannula.The cannula was discovered mounted to a fenestrated bipolar forceps, which displayed a broken main tube.As a result, the removal of the cannula became unfeasible.Nevertheless, after eliminating the broken pieces of the main tube, the cannula was effectively detached from the instrument.Following this, a thorough inspection of the cannula was conducted, revealing no issues.The fenestrated bipolar forceps instrument was analyzed and found to have a broken main tube at the distal tip.A piece measuring proximately 4,0mm x 3,0mm was not returned with the instrument.Components adjacent to this broken main tube do not show damage.The instrument came back attached with the following accessories.

• Brand Name: NONE
• Common Device Name: CANNULA, STANDARD, REUSABLE
• 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: 20003800
• Report Number: 2955842-2024-18304
• Device Sequence Number: 4915248
• Product Code: NAY
• UDI-Device Identifier: 00886874112137
• UDI-Public: (01)00886874112137(10)VE211601
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K131861
• 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): 07/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470002-08
• Device Catalogue Number: 470002
• Device Lot Number: VE211601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• 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: Initial
• 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