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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST PROGRASP FORCEPS Back to Search Results
Model Number 471093-11
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the prograsp forceps instrument involved with this complaint and completed the device evaluation. Failure analysis investigations replicated/confirmed the customer reported complaint "a small screw in the hinge that holds the two ends of the prograsp fell out¿. The instrument was found to have the grip pin dislodged at the distal end. The grips could not open and close properly. The pin was returned with the instrument, and no pieces were missing. The grips were realigned and the pin was re-installed. The grips were able to open and close properly, the pin showed no signs of physical damage. The root cause of dislodged instrument grips pin is attributed to manufacturing. A review of the site's complaint history does not show any additional complaints related to this product. Review of the provided image is consistent with the reported issue of the hinge pin falling out of the prograsp forceps. Root cause of the failure mode was confirmed with the returned device. A review of the instrument log was performed. The instrument was last used on (b)(6) 2021 on system (b)(4). The prograsp forceps had 11 uses remaining after the last use. The instrument has a maximum of 18 uses. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a small screw in the hinge that holds the two ends of the prograsp forceps fell out of the instrument and into the patient. Failure analysis confirmed the 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. Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. It is unknown if the initial reporter. Submitted a report to the fda.
 
Event Description
It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, a small screw in the hinge that holds two ends of the prograsp forceps fell out into the patient. The issue was immediately noticed and the surgeon was able to look back inside the patient, locate, and retrieve the screw. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the issue was identified in the middle of the case. No damage was noted at the beginning of the case. The fragment was retrieved with a laparoscopic d&g grasper. All fragments were retrieved; the customer saw only one screw pop out and verified all other parts were still on the instrument. The issue was noted while removing the instrument; no resistance was felt. There was no damage on the cannula seen. No other damage was seen on the instrument after removing it. There were no issues with the functionality of the instrument experienced. The instrument did not collide with any other instruments or hard materials. The staff did not need to perform an additional surgical procedure to remove the fragments. No post-op tests were performed. The customer has no idea what could have caused or contributed to the issue. There was no injury to the patient. The patient did not return to the hospital due to post-op complications. The instrument is available for return to isi. A picture is available for review. There is no patient information provided.
 
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Brand NameENDOWRIST
Type of DevicePROGRASP 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 Key12981985
MDR Text Key285071862
Report Number2955842-2021-11729
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471093-11
Device Catalogue Number471093
Device Lot NumberK13210830 0200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/13/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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