MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; POTTS SCISSORS

Model Number	470001-09
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting damaged, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The potts scissors instrument was analyzed and found to have a broken grip tip at the grip base.A piece approximately 0.148" x 0.055" was found to be broken off the broken piece was not returned.Common causes of the failure mode broken instrument grips -tips are typically attributed to misuse, such as excess force applied to the instrument jaws.This damage during use may result from applying excess force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal.The complaint regarding damaged was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.The probable root cause of a broken grip tip is attributed to damage during use, which may result from applying excess force on the instrument shafts and/or tips during handling, insertion, usage (overloading), or removal.This issue can be resolved by using an alternate instrument to complete the procedure.This complaint is being reported based on the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the potts scissors instrument were damaged.There was no report of patient involvement.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.

• Brand Name: ENDOWRIST
• Common Device Name: POTTS SCISSORS
• 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: 16704620
• Report Number: 2955842-2023-11848
• Device Sequence Number: 17047524
• Product Code: NAY
• UDI-Device Identifier: 00886874112120
• UDI-Public: (01)00886874112120(10)N10181126
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• 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
• Report Date (Section B): 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 470001-09
• Device Catalogue Number: 470001
• Device Lot Number: N10181126 0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown