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

Model Number 471093-11

Device Problem Difficult to Open or Close (2921)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 11/16/2021

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted pancreaticoduodenectomy procedure, the staff had to use the instrument release key (irk) to remove the prograsp forceps instrument.According to a nurse, the procedure was converted to open due to patient bleeding.The surgeon had reportedly cut/poked a vein.The surgeon attempted to stitch the vein but was unsuccessful and converted to an open procedure.While the staff was undocking, the prograsp forceps instrument was stuck on the tissue.The customer was not able to remove the instrument and had to use the irk.Intuitive surgical, inc.(isi) has attempted to obtain additional information from the surgeon concerning the reported event with no success.

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not yet received the prograsp forceps instrument that was requested for evaluation.Therefore, the root cause of the customer reported failure mode could not be determined.A follow up mdr will be submitted if additional information is received.A site history review was conducted and did not show any additional complaints related to this event.No image or video clip for the reported event was submitted for review.A review of the instrument logs was performed for a procedure on (b)(6) 2021 with system (b)(4).The logs show the customer last used the prograsp forceps instrument on (b)(6) 2021 during a pancreaticoduodenectomy procedure on system (b)(4).The instrument had 3 lives remaining.This last usage of the device per the log review matches the reported event date, indicating that the instrument was not used after the date of the reported event.A few of the reusable instruments used in the case were used in subsequent procedures.A site review shows no complaint filed against any of the other instruments used in this procedure.A system log review was conducted for a procedure on (b)(6) 2021 on system (b)(4).The system logs reveal a single error #22027 occurred.This error was generated when the system detected the use of a grip release tool on universal surgical manipulator (usm) #4 with prograsp forceps instrument (sn: (b)(4)) installed.At the same time, a single error #26008 was generated and involved usm #4.This error is generated when the system detects instrument manual grip release misuse and signifies that the user may be attempting to use the emergency grip release without pressing the e-stop.Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted pancreaticoduodenectomy procedure, it was alleged that the surgeon injured a vessel which resulted with bleeding.The surgeon then elected to convert to open surgery.During the event, the prograsp forceps instrument was allegedly stuck on tissue and an emergency wrench was used to release from the instrument from the patient.At this time, it is unknown what caused the unclamping event to occur.Per subsequent follow up, the customer informed a vein was cut/poked and a bleeding event occurred.At this time, the causes of the vessel injury and customer reported failure mode are unknown.Blank mdr fields: follow-up was attempted, but the missing patient information in sections a and b 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.

• 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: 12981694
• MDR Text Key: 287399197
• Report Number: 2955842-2021-11726
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119785
• UDI-Public: (01)00886874119785(10)K10210329
• 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,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2021
• 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: K10210329 0458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• 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.