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

Model Number 470093-11

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the prograsp forceps instrument be returned for failure analysis to be performed, but the instrument has not yet been received.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A review of the site's complaint history does not show any additional complaints related to this product or this event.A review of the instrument log was performed.Per the review, the instrument was last used on (b)(6) 2021 on system sk4563.The instrument had 8 uses remaining after last use.No image or procedure video was provided for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: the instrument could not be removed from the cannula due to an unknown loose component.The unknown loose component could indicate that a pin was insufficiently swaged.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 that during a da vinci-assisted surgical procedure, the base of the end effector of the prograsp forceps instrument broke down and turned 30 degrees to the central axis when the site tried to close the instrument jaws.It was not possible to withdraw the instrument from the cannula.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up on 29-nov-2021 and obtained the following additional information: no fragment fell into the patient.There was no harm or injury to the patient.The instrument broke down before it touched the patient¿s tissue.The instrument was removed along with the cannula since it was not possible to remove the instrument from the patient¿s body due to the break in the base of the end effector.The operation was prolonged by 10 minutes due to the issue.The instrument is available for return to isi for evaluation.The video recording of the procedure was requested from the doctor, but was not provided to isi at the time of this report.The patient¿s year of birth was (b)(6).No relevant tests were performed.The relevant patient history was not provided, as it is the hospital¿s confidential 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: 12977065
• MDR Text Key: 289907958
• Report Number: 2955842-2021-11712
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112267
• UDI-Public: (01)00886874112267(11)210114(10)N10210118
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/16/2021

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
• Device Operator: Health Professional
• Device Model Number: 470093-11
• Device Catalogue Number: 470093
• Device Lot Number: N10210118 0012
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2021
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 98 KG