MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MEGA SUTURECUT ND

Model Number	470309-14
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received the mega suturecut needle driver instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.Per log review, the incisional hernia tapp procedure via system sk2194 that took place on (b)(6) 2022 used two mega suturecut needle driver instruments.At this time, it is unknown which instrument had the alleged issue.1.Mega suturecut needle driver (part # 470309-14 / lot # n10190301-0007) was last used on 19-aug-2022.There was 2 uses remaining after this last usage.There is no indication that this instrument was used in subsequent procedures after the alleged event reported in this record.2.Mega suturecut needle driver (part # 471309-15 / lot # k12220208-0468) was last used on 19-aug-2022.There was 9 uses remaining after this last usage.There is no indication that this instrument was used in subsequent procedures after the alleged event reported in this record.Images associated with this reported event were not submitted for review.This complaint is considered a reportable event due to the following conclusion: it was alleged that during a da vinci-assisted incisional hernia tapp surgical procedure, the mega suturecut needle driver instrument broke near the cut portion of the jaw.Pieces fell into the patient and were retrieved by the surgeon in the same procedure.
Event or Problem Description
It was reported that during a da vinci-assisted incisional hernia tapp surgical procedure, the intuitive surgical, inc.(isi) clinical sales representative (csr) called the isi technical service engineer (tse) and stated that the mega suturecut needle driver instrument broke near the cut portion of the jaw.Pieces fell into the patient and were retrieved by the surgeon.The tse recommended returning the failed instrument for failure analysis.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following additional information: the surgeon stated that, while passing a needle from one hand to the instrument, the instrument collided with the needle.At that time, the surgeon noted a fragment falling into the patient.Under direct visualization, the surgeon used a maryland bipolar forceps instrument to retrieve the fragment laparoscopically.No post-operative testing was performed as a result of the reported issue.Additionally, the surgeon indicated that the instrument had been removed during the procedure (prior to the breakage).The wrist of the instrument was straightened prior to removal.Nothing out of the ordinary was observed by the staff during instrument removal.The surgeon was uncertain as to whether or not the instrument had been inspected prior to use and not able to tell how long the instrument had been in use leading up to the break.The surgeon observed no change in instrument functionality prior to the reported issue.The patient was reported to not have sustained any injury and had not returned to the hospital with any post-operative complications related to retaining a foreign object.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received userfacility report (b)(4) stating: "davinci needle driver tip broke in half inside the patient during surgery.The broken piece was retrieved intact.No harm to the patient.".
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Common Device Name: MEGA SUTURECUT ND
• 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: 15443585
• Report Number: 2955842-2022-14079
• Device Sequence Number: 20760511
• Product Code: NAY
• UDI-Device Identifier: 00886874112434
• UDI-Public: (01)00886874112434(10)N10190301
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 470309-14
• Device Catalogue Number: 470309
• Device Lot Number: N10190301 0007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/18/2022
• Supplement Report FDA Received Date: 10/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• 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: Unknown