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	02/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cannula, 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.The reducer has not been returned for evaluation.Therefore, failure analysis of the product related to the complaint cannot be performed.A site history complaint review was performed and no related complaints were found for the product.Verification of the product and event details via system logs cannot be performed at this time because there is insufficient product and/or event date information.No image or video clip of the reported event was submitted for review.Based on the information available, this complaint is being reported based on the following conclusion: during a surgical procedure the reducer broke and the pieces fell inside the patient.Although there was no patient injury as a result of the issue, if this failure were to recur, it could cause or contribute to an adverse event.
Event or Problem Description
It was reported that during a gastroplasty the customer had the reducer break into two pieces inside the patient.The two pieces were retrieved.The procedure was completed with a backup reducer with no patient harm.Intuitive surgical inc.(isi) followed up with the customer to request additional information, but the customer confirmed that there were no further details available related to the event.In addition, no patient-related information was available.
Additional Manufacturer Narrative
Additional information can be found in the following fields: d9, g3, g6, h2, h3, h6, and h10.Device evaluation information can be found in the following fields: h6 and h10.D11 - intuitive surgical, inc.(isi) received the reducer related to this complaint and evaluation was performed.Failure analysis confirmed that the blue seal inside the reducer was found to be broken.A piece approximately 0.052" x 0.128" was broken off and was not returned.The root cause of the breakage was attributed to mishandling/misuse.No other damage was found.
Event or Problem Description
Refer to h10/h11 for follow-up information.
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".

• 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: 11543182
• Report Number: 2955842-2021-10294
• Device Sequence Number: 14580517
• Product Code: NAY
• UDI-Device Identifier: 10886874112585
• UDI-Public: (01)10886874112585(10)L10201001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2021

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: L10201001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/26/2021; 02/22/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/21/2021; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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: Unknown