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	04/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the cannula reducer involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed and replicated the customer reported complaint of "the metal round tip came off from the reducer".The accessory was found to have a dislodged conductor.The conductor, measuring 0.440" x 0.560" was returned.No broken or missing pieces were observed.The conductor was reseated on the cannula and could easily be removed with little force.Upon visual inspection, there was no physical damage observed.Root cause is not established.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.No image or video clip for the reducer tip that was retrieved was submitted for review.A review of instrument log could not be performed as accessories do no get tracked in logs.This complaint is deemed a reportable event due to the following conclusion: the metal round tip of the cannula reducer reportedly fell inside the patient and was retrieved with no additional surgical intervention required.However, unintended accessories falling into the patient may require surgical intervention.At this time, it is unknown what caused the tip of the reducer to fall into the patient.Although there was no patient injury reported, if the event were to recur, it could cause or contribute to an adverse event.If additional information related to this complaint is obtained, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the metal round tip of the cannula reducer fell into the patient.The tip was retrieved during the same procedure with a grasper.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
This event was determined to be related to isifa2021-08-r.
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.B1 updated from "product problem" to "adverse event and product problem".H1 updated from "malfunction" to "serious injury".

• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11823943
• Report Number: 2955842-2021-10506
• Device Sequence Number: 14400120
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(10)L10210212
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2021

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: L10210212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 04/16/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 01/05/2022; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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: Initial
• 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