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

Model Number 471093-11

Device Problem Component Missing (2306)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the reported failure of "issue with cable or pin".Failure analysis found the prograsp forcep's grip pin was missing at the distal end.The pin was not returned with the instrument.The root cause of the missing grip pin is typically attributed to manufacturing.A review of the instrument log for the product associated with this event shows that the prograsp forceps were last used on the reported event date of (b)(6) 2021 on system (b)(4).There was no indication that the instrument was used in subsequent procedures after the alleged event reported on this record.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.The alleged event occurred with 13 uses remaining on the instrument.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: failure analysis confirmed the instrument's grip pin was missing 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 that prior to the start of a da vinci-assisted surgical procedure, an issue was noted with the prograsp forceps.The customer noted that they were "not sure if it is a cable or pins".The procedure was reportedly completed with no patient injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information related to the reported event.However, no further details have been obtained 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12381313
• MDR Text Key: 268661723
• Report Number: 2955842-2021-11025
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119785
• UDI-Public: (01)00886874119785(10)N10200831
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/03/2021

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: N10200831 0111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2020
• 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