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

Model Number	470001-08
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
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 frayed grip cable at the distal end on the grip hub.Some bundles/filaments of the cable were frayed but the cable is not fully broken as reported by the customer.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.The components surrounding the frayed cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable fraying.The complaint was confirmed by failure analysis.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the potts scissors instrument had a broken pulley wire.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the potts scisscors instrument involved with this complaint to perform failure analysis; however, the evaluation is not yet complete.A follow-up mdr will be submitted once the product is evaluated and/ or if additional information is received.

• Brand Name: ENDOWRIST
• Common Device Name: POTTS SCISSORS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 19717536
• Report Number: 2955842-2024-16912
• Device Sequence Number: 8130351
• Product Code: NAY
• UDI-Device Identifier: 00886874112120
• UDI-Public: (01)00886874112120(10)N10170412
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 06/17/2024

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: 470001-08
• Device Catalogue Number: 470001
• Device Lot Number: N10170412 0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2017
• 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