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	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cannulae, obturators, seals, and related accessories have applications in endoscopic surgery to establish a port of entry for intuitive surgical da vinci endowrist and single-site instruments, endoscopes, or compatible accessories.They are intended to be used only in a medical facility, by trained medical professionals, in accordance with the user manual for the da vinci system.Intuitive surgical, inc.(isi) received the reducer involved with this complaint and completed the product evaluation.Failure analysis replicated the reported issue.Visual inspection was performed and the reducer was found to be broken.The conductor was found to be dislodged.No material appeared to be missing.The reducer metal tip was measured for mating features and seemed to be dimensionally within specification.Mating keys that engage with the reducer tip seemed to be within specification, but the fit felt very loose.Per the sub-assembly pn 341529-09 drawing, the tip should withstand a 5 lbf pull force.Assembly was pull tested 5 times in house and every pull test was below the 5 lbf specification, with the average pull force being roughly 1 lbf.Test results suggested the fit between the reducer tip and cannula was loose, and that is likely why the tip detached during use.Root cause was likely manufacturing related.A site history complaint review was performed and no related complaints were found for this product.No image or video clip for the reported event was submitted for review.Based on the information provided, this complaint is considered a reportable malfunction due to the following conclusion: all fragments were retrieved during the same procedure and no additional surgical intervention was required.However, unintended fragments falling into the patient may require surgical intervention.Follow-up was attempted, but the patient information for the blank fields was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the tip of the reducer came off and fell inside the patient.The procedure was reportedly completed.Intuitive surgical, inc.(isi) followed up with the isi clinical sales rep (csr) and obtained the following additional information on 13-july-2021.It was confirmed that the fragment was retrieved from the patient.There was no patient harm and no post-op complications.The reporter was unable to confirm if there were any instrument collisions or interaction with hard surfaces.The cause of the instrument breakage was unknown.No patient demographic information was available.
Additional Manufacturer Narrative
This event was determined to be related to (b)(4).
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: 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: 12292254
• Report Number: 2955842-2021-10907
• Device Sequence Number: 4673122
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(10)L10210128
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2021

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: L10210128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 07/13/2021
• Initial Report FDA Received Date: 08/08/2021
• Supplement Report FDA Received Date: 01/05/2022; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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: Reuse
• 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; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White