MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC WECK VISTA; BLADELESS OBTURATOR

Model Number	470359-03
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	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The optical obturator has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.A review of the site¿s system logs confirmed that the customer performed a cholecystectomy procedure on (b)(6) 2022 on system sk5911.Image(s) and/or video clip(s) associated with this reported event were not submitted for review.An advanced technical review was performed by a clinical development engineer (cde) to clarify the possibility of a fragment falling into the patient (ffip).The cde stated that it would depend upon where the piece broke from, to determine if it could lead to ffip.If the piece broke off the septum of the obturator, it is possible that the piece gets pushed down the shaft of the obturator while inserting the endoscope and lands in the optical tip of the obturator.Any other piece like the latch, etc.Will be outside the patient's body and is less likely to fall into the patient during first entry.This complaint is being reported based on the following conclusion: the complaint acknowledges that a fragment fell from a portion of the device that was seen in a portion of the accessory that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Follow-up was attempted, but the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for the model # is not applicable.Implant date is blank because the product is not implantable.Information for the initial reporter name and address is not available.Initial reporter occupation is blank because the information was not provided.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, a piece of plastic broke off of the optical obturator and fell into the optical tip of the obturator when the trocar was being placed.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following additional information: the surgeon confirmed that it occurred during his cholecystectomy procedure on (b)(6) 2022.The surgeon corrected the information that was initially provided and stated that there were no fragments that fell into the patient and that the piece that fell was in between the view of the scope lens and the optical tip of the obturator.There was no patient harm due to the issue and there were no fragments that needed to be retrieved from the patient.The 8mm optical obturator was removed and replaced with a regular 5mm optical obturator and then they replaced that with a regular 8mm obturator without an optic view.The procedure was completed robotically with no patient injury.No images or patient demographics were available.

• Brand Name: WECK VISTA
• Common Device Name: BLADELESS OBTURATOR
• 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: 15991740
• Report Number: 2955842-2022-15922
• Device Sequence Number: 14883990
• Product Code: GCJ
• UDI-Device Identifier: 10886874112523
• UDI-Public: (01)10886874112523(10)U10220616
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K152663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2022

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: 470359-03
• Device Catalogue Number: 470359
• Device Lot Number: U10220616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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: Unknown
• 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