MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC NONE; ARM DRAPE

Model Number	470015-07
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the sterile drape involved with this complaint and completed the device evaluation.The reported event was not reproduced during failure analysis (fa) investigation.The drape was tested with an in-house system and found no issue.The system passed recognition and engagement test and moved intuitively in all directions.There was no damage found on the sterile adapter.A review of the site's complaint history does not reveal any related complaints involving this product or this event.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: during a da vinci assisted low anterior resection, the medium-large clip applier instrument exhibited non-intuitive movement.Troubleshooting was performed by the customer and the issue was resolved.The case was completed robotically and no known patient impact was reported.At this time, the cause of the customer¿s reported failure mode is unknown.
Event or Problem Description
It was reported that during a da vinci-assisted low anterior resection procedure, the medium-large clip applier instrument exhibited non-intuitive movement.The instrument jaw allegedly "moved in the wrong direction." troubleshooting was performed by removing and reinstalling the same instrument back into the arm and this resolved the issue.Following this, the instrument movement was confirmed and operated without error.The user completed the procedure with no further issue reported.The user suspects a faulty drape.No fragment fell into the patient.No known impact or patient consequence was reported.

• Brand Name: NONE
• Common Device Name: ARM DRAPE
• 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: 14863899
• Report Number: 2955842-2022-12597
• Device Sequence Number: 5450651
• Product Code: NAY
• UDI-Device Identifier: 10886874112196
• UDI-Public: (01)10886874112196(10)DM2191602
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2021

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: 470015-07
• Device Catalogue Number: 470015
• Device Lot Number: DM2191602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2019
• 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 Sex: Unknown