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	Foreign Body In Patient (2687)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Isi has not yet received the bladeless obturator for evaluation.Therefore, the root cause of the customer reported failure mode could not be determined.A follow up mdr will be submitted if additional information is received.No image or video clip for the reported event was submitted for review.A review of the site's complaint history does not show any additional complaints related to this product.Based on the information provided at this time, this complaint is being classified as a reportable event due to the following conclusion: during a da vinci-assisted total hysterectomy surgical procedure, a fragment from the bladeless obturator broke and fell inside the patient.No fragment was found upon searching, but the accessory appeared to be broken at the tip with a piece missing.The procedure was completed with no reported injury.Unintended fragments falling inside the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.While there was no harm or injury to the patient, the reported failure mode could cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted total hysterectomy surgical procedure, a fragment from the bladeless obturator broke and fell inside the patient.Reportedly, the customer looked for fragments inside the patient's anatomy, but no fragments were found.The procedure was completed and when comparing the bladeless obturator that was used in this procedure to another bladeless obturator, the front tip looked broken.The customer could not confirm that fragments remained inside the patient's anatomy, but a piece appeared to be missing, and no fragments were found upon searching.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the fragment was not retrieved.The surgeon believed the camera trocar and bladeless obturator hit each other when inserting the trocar, and the front tip of the obturator broke and fell inside the patient's abdominal cavity.The accessory was inspected prior to use and there was no damage or anything out of the ordinary identified.There was no injury to the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The accessory is available for return to isi for evaluation.No photographic images or video recording of the procedure were available for isi review.
Additional Manufacturer Narrative
Additional information can be found in the following sections: d9, g3, g6, h2, h3, h6 and h10.D11 - the bladeless obturator has been returned and evaluated by the failure analysis team.Failure analysis investigations replicated and confirmed the customer reported complaint of "front tip has been broken." the very tip of the obturator was found to be broken.Approximately 0.020" x 0.052" was broken off and was not returned.The root cause of this failure is attributed to mishandling/misuse.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1.B1 updated from "product problem" to "adverse event and product problem".B2 updated to "required intervention".H1 updated from "malfunction to serious injury".
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11356880
• Report Number: 2955842-2021-10164
• Device Sequence Number: 3415698
• Product Code: GCJ
• UDI-Device Identifier: 10886874112523
• UDI-Public: (01)10886874112523(10)M11190812
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152663
• 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,Followup,Followup
• Report Date (Section B): 01/27/2021

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: 470359-03
• Device Catalogue Number: 470359
• Device Lot Number: M11190812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 02/24/2021; 02/24/2021
• Initial Report FDA Received Date: 02/21/2021
• Supplement Report FDA Received Date: 03/21/2021; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2019
• 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: 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: Female