MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CADIERE FORCEPS

Model Number	420049-12
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	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted biliodigestive bypass surgical procedure, the pulley cables on the cadiere forceps were exposed and broken.The surgeon had used the cadiere forceps as a separator with no issue in the last five hours prior to the instrument breakage.The surgeon was not grabbing anything within the jaws when the incident occurred.The customer then straightened, opened, and removed the instrument.The procedure was completed with no reported injury.Intuitive surgical inc.(isi) followed up with the customer to confirm that the cadiere forceps was inspected prior to use.The cadiere forceps did not collide with any other instruments.No fragments fell inside the patient.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The cadiere forceps instrument was analyzed and found to have a broken distal pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing from the clevis.However, no damage was observed on the pulleys or the backend after removing the housing.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.

• Brand Name: ENDOWRIST
• Common Device Name: CADIERE FORCEPS
• 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: 17865014
• Report Number: 2955842-2023-18941
• Device Sequence Number: 6073457
• Product Code: NAY
• UDI-Device Identifier: 00886874111338
• UDI-Public: (01)00886874111338(10)N10180924
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2023

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: 420049-12
• Device Catalogue Number: 420049
• Device Lot Number: N10180924 421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2018
• 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 Age: 47 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Hispanic