MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; BLUNT OBTURATOR, LONG

Model Number	470009-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the handle and the head of the obturator were separated.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
A return material authorization (rma) was issued to evaluate the instrument; however, intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the reported failure mode has not yet been determined.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) contacted the initial reporter and was able to obtain the following information: the obturator was inspected prior to use, and nothing was out of the ordinary.The handle separated from the distal end of the obturator (a part that enters the patient).The thyroidectomy procedure was completed with a backup obturator.There was no injury to the patient and there are no photos or videos for isi to review.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the obturator to perform failure analysis (fa).Fa was able to confirm and reproduce the customer reported complaint.The handle of the obturator was found to be broken at the proximal end close to the latch.The probable root cause is attributed to damage during use or reprocessing.Damage can result from mechanical impact, such as accidental drops of the accessory or inadvertent collisions with hard surfaces during handling or usage.Improper cleaning during reprocessing, such as prolonged exposure of the accessory to harsh cleaning agents, can lead to cracking.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: NONE
• Common Device Name: BLUNT OBTURATOR, LONG
• 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: 24426215
• Report Number: 2955842-2026-07261
• Device Sequence Number: 12837038
• Product Code: NAY
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2026

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: 470009-07
• Device Catalogue Number: 470009
• Device Lot Number: SR2416001 NA
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/01/2026; 04/20/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/26/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2024
• 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
• Patient Sex: Unknown