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

Model Number 470093-11

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/04/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc. (isi) received the 8mm prograsp forceps instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) replicated/ confirmed the customer reported complaint. Failure analysis found the primary finding of the grip pin workmanship issue to be related to the customer reported complaint. The 8mm prograsp forceps instrument was found to have a dislodged grip pin. The pin measured approximately 0. 073" x 0. 250" and was not returned. The grip did not exhibit any damage and the root cause of this failure is attributed to manufacturing. A review of the instrument log for the prograsp forceps (470093-11/n131907290109) associated with this event has been performed. Per logs, the prograsp forceps was last used on (b)(6) 2021 on system (b)(4). The alleged instrument had 1 use remaining after the last procedural use. A review of the site's complaint history found that there were no other complaints for this product. No image or video of the last procedure was provided for review. Based on the information provided at this time, this complaint is being reported based on the failure analysis findings. Failure analysis confirmed the prograsp forceps instrument's grip pin was dislodged with no evidence of user mishandling/misuse. This instrument is designed with a grip pin on the distal end allowing articulation of the instrument assemblies they are holding together and is secured to the device by swaging. If the pin is not properly fused together, the pin could become dislodged and fall into the patient. 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 during a da vinci-assisted surgical procedure, the 8mm prograsp forceps instrument did not grasp the tissue or clamp shut due to a loose tip. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.

• 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: 13102342
• MDR Text Key: 288671841
• Report Number: 2955842-2021-11827
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470093-11
• Device Catalogue Number: 470093
• Device Lot Number: N13190729 0109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2019
• 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 Treatment Data

Date Received: 12/28/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES