MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; SUCTION/IRRIGATOR

Model Number	410299-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure the suction irrigator broke and the customer was unable to remove the irrigator normally.The customer removed the instrument and cannula, and was able to get the instrument out, but further damage was done to the instrument to get it out.The customer continued with a new cannula and instrument.The procedure was completing as planned with no reported injury.The clinical sales representative informed that the suction irrigator instrument was working fine, then the surgical tech pulled the instrument to install a different type of instrument into the arm.When the surgical tech wanted to place the suction irrigator instrument back on to the arm, it would not go through the reducer.At that time, the tech obtained a new reducer and placed the suction irrigator instrument in, however, noticed that it became stuck.The surgical tech removed the trocar, instrument together, and was able to release the instrument.When the instrument was removed, it was observed the instrument was broken at the hinges.It was confirmed that no fragments fell into the patient.The procedure was completed robotically with no patient injury or harm.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the suction irrigator instrument involved with this complaint and completed the device evaluation.Failure analysis found the instrument distal tip broken off.The broken distal tip was not returned with the instrument.The instrument was also found to have the snake wrist disk dislodged and disk cables broken.The instrument was found to have the inner lumen missing.The inner lumen was not returned with the instrument.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: SUCTION/IRRIGATOR
• 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: 17038569
• Report Number: 2955842-2023-15370
• Device Sequence Number: 15180563
• Product Code: NAY
• UDI-Device Identifier: 10886874111106
• UDI-Public: (01)10886874111106(10)M10200112
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K110451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

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: 410299-03
• Device Catalogue Number: 410299
• Device Lot Number: M10200112 389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• 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: Unknown
• 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: 78 YR
• Patient Sex: Male