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

Model Number 471093-11

Device Problems Material Fragmentation (1261); Difficult to Remove (1528)

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

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the prograsp forceps instrument, but failure analysis has not yet been completed.Therefore, the root cause of the reported failure mode has not yet been determined.A follow-up mdr will be submitted after failure analysis investigation and if additional information is obtained.

Event Description

It was reported that during a da vinci-assisted inguinal hernia surgical procedure, the tip end of a prograsp forceps instrument broke inside the patient and was unable to be removed from trocar the procedure was completed with no reported injury.

Manufacturer Narrative

The prograsp forceps instrument has been returned and evaluated by the failure analysis team.Failure analysis investigations confirmed the customer reported complaint.The instrument was found to have the main tube broken.A piece measuring proximately 0.158¿ x 0.296¿ was not returned with the instrument.An additional observation not reported by site indicated that the instrument was found to have a broken roll gear output at the proximal end of the main tube.A piece measuring approximately 0.187" x 0.369" was not returned with the instrument.

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: 18509404
• MDR Text Key: 333136216
• Report Number: 2955842-2024-10321
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119785
• UDI-Public: (01)00886874119785(11)230720(10)K11230720(91)0017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214095
• 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: 12/22/2023

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: K11230720 0281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/13/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2023
• 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