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 Unspecified Tissue Injury (4559)

Event Date 02/26/2024

Event Type  Injury  

Manufacturer Narrative

The prograsp forceps instrument has not been returned to intuitive surgical, inc.(isi) for failure analysis investigation.System/instrument logs were unable to be performed due to insufficient information provided.

Event Description

It was reported that during a davinci assisted benign hysterectomy surgical procedure, the prograsp forceps instrument broke and was jammed in one position.The instrument was not attached to any tissue inside the patient.The surgeon was unable to straighten the instrument.As a result, the procedure was converted to an open surgery to remove the jammed instrument along with the cannula.It was also reported that a fragment fell into the patient and was retrieved during the same procedure.Following the procedure, the staff tried to assess the damage but could not straighten the instrument to remove it from the cannula; however, the instrument was still jammed. the instrument was inspected prior to use with no issue identified.It was confirmed that the patient did not experience any post-operative complications.

• 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: 19180444
• MDR Text Key: 341019329
• Report Number: 2955842-2024-13734
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119785
• UDI-Public: (01)00886874119785(11)230810(10)K10230810
• 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,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471093-11
• Device Catalogue Number: 471093
• Device Lot Number: K10230810 0099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female