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

Model Number 471093-11

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has requested that the prograsp forceps instrument be returned for evaluation.However, it has not yet been received as of the date of this report.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.

Event Description

It was reported that during a da vinci-assisted myomectomy surgical procedure, the prograsp forceps instrument broke and was unable to be removed through the cannula.The customer was able to remove the instrument with the cannula.They will return the instrument with the cannula as they cannot get the cannula off of the broken instrument.They believed they had retrieved all of the fragments from the instrument.Intuitive surgical, inc.(isi) followed up with the customer on and obtained additional information: the procedure was completed robotically.There was a delay of roughly 30 minutes.The instrument is available for return.The small fragments were discarded and would not be returned.The instrument was inspected prior to use with no noted damage.The reason the instrument and cannula were removed together was due to the wrist not being able to be straightened.The port size was increased to remove the cannula and instrument together.The incident did involve fragments falling inside the patient as a result of the instrument issue.The surgeon confirmed that all fragments were removed during the same procedure.There were no post-operative tests like an x-ray or ultrasound performed to check for remaining fragments.The patient did not return to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.

• 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: 17962508
• MDR Text Key: 326004517
• Report Number: 2955842-2023-19380
• Device Sequence Number: 1
• Product Code: NAY
• 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,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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