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

Model Number 471093-11

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the prograsp forceps instrument and performed a device evaluation.Failure analysis confirmed the reported issue.The instrument was found to have the grip pin improperly swaged.As a result the grips were dislodged and not functional.The root cause of this failure is attributed to manufacturing.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the device logs for the prograsp forceps (part# 471093-11 | lot-sequence# k11211004- 0054) associated with this event has been performed.Per this review of the logs, the prograsp forceps was last used on (b)(6) 2022 during a cholecystectomy procedure on system serial# (b)(4).No image or video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: failure analysis confirmed the instrument's grip pin was dislodged due to improper swaging.This instrument is designed with a grip pin on the distal end allowing articulation of the instrument assemblies they are holding together and is secured to the device by swaging.If the pin is not properly fused together, the pin could become dislodged and fall into the patient.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

Event Description

It was reported during central processing and cleaning, the instrument jaws were not opening and closing properly.There was no report of patient harm, adverse outcome or 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.

• 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: 14132060
• MDR Text Key: 298877559
• Report Number: 2955842-2022-11097
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119785
• UDI-Public: (01)00886874119785(10)K11211004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2022
• 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: K11211004 0054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• 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