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

Model Number	420093-14
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy procedure, one side of the prograsp forceps instrument jaw was not moving smoothly.The instrument was removed and it was observed that a wire had become dislodged within and ¿the disc¿ did not work.It was reported that tissue was lodged in the small crevices of the instrument.Immediately after removing the instrument, minor tissue damage was identified when the surgical staff checked the path of removal of the prograsp forceps instrument from the cannula to the target tissue to ensure there were no issues in the abdominal cavity.It is unknown as to what type of minor tissue damage/injury was noted on the inside of the peritoneum.There was no bleeding observed and no fragments fell inside the patient¿s body.When checking the instrument after removal, they ¿restored¿ the wire and the prograsp forceps still did not move.After consulting with the general surgery colorectal team, the minor tissue damage was repaired with two stitches.The procedure was completed robotically using a back-up prograsp forceps instrument.The surgeon did not administer any additional treatment to the tissues.The patient did not experience any post-operative complications.The patient¿s current status is ¿no problem¿.
Additional Manufacturer Narrative
Based on the current information provided, the cause of the operative complication has been determined to be component failure.The prograsp forceps instrument involved with this event has been received and investigations completed.Failure analysis investigations confirmed and replicated the customer reported complaint.The instrument was found to have a loose grip cable at the distal end.Loose instrument grip cables are attributed to a component failure and to a loss of cable tension.Review of the system log was not performed because the system logs are not available at this time.The system was not connected to onsite.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: 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: 17627871
• Report Number: 2955842-2023-18028
• Device Sequence Number: 7302201
• Product Code: NAY
• UDI-Device Identifier: 00886874111345
• UDI-Public: (01)00886874111345(10)K10230209
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: 420093-14
• Device Catalogue Number: 420093
• Device Lot Number: 998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Male