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

Model Number 471093-11

Device Problem Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

It was reported that after a da vinci assisted surgical procedure, the cable of the prograsp forceps instrument was noted to be frayed.The procedure was completed with no patient injury.Intuitive surgical, inc.(isi) has performed follow-up to request additional information related to the reported event.However, as of the date of this report, no further details have been received.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the customer reported complaint.The instrument was found to have a frayed grip cable at the distal idler pulley.The frayed cable strands stuck out at the wrist.Additionally, the main tube exhibited signs of scratch marks/abrasions on the distal end.The main tube scratch marks measured roughly 0.03" to 0.24" in length and were not aligned with the tube axis.Material was missing from the surface of the main tube.A review of the site's complaint history does not show any additional reportable complaints related to this product and/or this event.No images or procedure video were provided for review.Event verification: a review of the instrument log for the prograsp forceps (pn 471093-11 / lot n11210222 0048) associated with this event has been performed.Per logs, the prograsp forceps was last used on (b)(6) 2021 on system sk2447, with 13 uses remaining.Based on the information provided at this time, this complaint is being reported due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient.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 and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Not applicable because the product is not implantable.The information for blank fields is not available.Fields are not applicable.

Manufacturer Narrative

Intuitive surgical, inc.(isi) obtained the following information from the customer about the complaint: "the patient was male, 78 years old, dob (b)(6) 1943.Other questions have been transferred to the surgeon.".

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: PROGRASP 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: 13720237
• MDR Text Key: 287259090
• Report Number: 2955842-2022-10562
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119785
• UDI-Public: (01)00886874119785(10)N11210222
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471093-11
• Device Catalogue Number: 471093
• Device Lot Number: N11210222 0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Age: 78 YR
• Patient Sex: Male