MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; REDUCER

Model Number	470381-11
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	07/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the reducer associated with this complaint and completed investigations.Failure analysis investigation was able to confirm/ reproduce the reported complaint.The reducer was found to be broken and the silver tip was able to be pulled off.There were no broken pieces.Advanced failure analysis engineer conducted further investigation and attributed this to manufacturing based on the reducer tip investigation.The root cause has been identified as a missing undercut feature on specific lots of the reducer tip subassembly.A product investigation report has been initiated to further investigate the root cause advanced failure analysis engineer conducted further investigation via a product investigation report and attributed this failure mode to be a manufacturing issue at the subcomponent supplier.A log review could not be performed on the reducer because the item does not get captured in the logs.A review of the site's complaint history shows no other complaints related to this product.Review of the provided images are consistent with the alleged complaint of the tip was missing from the reducer.This event has been deemed as a reportable event because it was alleged the tip of the reducer fell inside the patient during a da vinci assisted procedure with no evidence or claim of user mishandling/ misuse.The reported failure mode could likely cause or contribute to an adverse event if it were to recur as unintended fragment falling into the patient may require surgical intervention.Follow-up was attempted, but the missing patient information in was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.
Event or Problem Description
It was reported that during a 6-hour da vinci-assisted surgical procedure, when the surgeon had pulled out his hand from a gel port, the broken tip of the reducer was in his hand.The reducer was removed from the trocar and verified that the tip was missing.The fragment was retrieved from the patient during the same procedure.An x-ray was taken in the operating room the same evening.According to the surgeon, he did not know the reducer was broken or what may have caused the breakage.The reducer along with the tip were cleaned and returned to isi.
Additional Manufacturer Narrative
This event was determined to be related to (b)(4).
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.

• Brand Name: ENDOWRIST
• Common Device Name: REDUCER
• 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: 12911116
• Report Number: 2955842-2021-11635
• Device Sequence Number: 11949786
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(10)M10210429
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K162411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2021

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: 470381-11
• Device Catalogue Number: 470381
• Device Lot Number: M10210429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 07/30/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 01/05/2022; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2021
• 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: ISIFA2021-08-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Unknown