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

Model Number 471093-11

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The prograsp forceps instrument was analyzed and found to have a broken main tube.The instrument was found to have the main tube broken.A piece measuring proximately 1.50 mm x 1.80mm was not returned with the instrument.A review of the provided images is consistent with the complaint of a defective prograsp forceps instrument.Image review was then performed by an intuitive surgical, inc.(isi) advance failure analysis.The following additional information was provided: it looks like the main tube may be broken and as a result the proximal clevis is dislodged from its normal position on the main tube.

Event Description

It was reported that during a davinci assisted malignant hysterectomy surgical procedure, a prograsp forceps instrument could not be removed from arm.The instrument appeared to be damaged at the end.The customer had to had to remove cannula and instrument from the arm in one go because the instrument could not be removed from the cannula.Surgeon confirmed no harm to patient and no fragments broken off.Procedure completed on the da vinci using a new cannula and instrument with a delay of about 15-20 mins.

• 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: 18795159
• MDR Text Key: 336398826
• Report Number: 2955842-2024-11903
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/16/2024

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
• Device Operator: Health Professional
• Device Model Number: 471093-11
• Device Catalogue Number: 471093
• Device Lot Number: N10210119 0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2021
• 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 Sex: Female