MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CROCKODILE GRASPER

Model Number	478059-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the jaw of the crocodile grasper broke and fell inside the patient's abdomen.A backup instrument was used to continue.All fragments were retrieved and no additional surgical intervention was required.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the operating room (or) nurse and obtained the following additional information: the patient is korean/asian.The customer retrieved the fragments using a laparoscope.All fragments were retrieved with no additional surgical procedure required.The customer did not perform any post-operative tests to check for remaining fragments.The surgeon continued using the instrument in the surgery from morning to afternoon.The instrument was inspected prior to use.The instrument was grasping tissue when the issue occurred.During the procedure, the surgeon felt a little stiff while opening the tip.The instrument did not collide with any other instruments or other hard material during the surgical procedure.The instrument was never removed prior to the breakage.Upon the final removal of the instrument, the wrist was straightened.The surgical staff did not feel any resistance upon removal of the instrument through the cannula.The surgical staff did not notice any damage to the cannula or to the instrument after the event occurred.There was no injury to the patient.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The instrument is available for return to isi for evaluation.There were no photographic images of the device(s) or a video recording of the procedure available for isi review.
Additional Manufacturer Narrative
Isi received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.The instrument was found to have the plastic proximal clevis broken, causing the grip tips to dislodge.The broken piece was returned.This failure is most commonly caused by mishandling/misuse, such as excess force applied to the distal end of the instrument.A review of the site's instrument logs was conducted.Investigation revealed the crocodile grasper instrument (pn 478059-04/ lot # n10181105-0028) was last used during a surgical procedure on (b)(6) 2020 on system sk3182.The instrument has 3 lives remaining.

• Brand Name: SINGLE-SITE
• Common Device Name: CROCKODILE GRASPER
• 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: 16928147
• Report Number: 2955842-2023-13567
• Device Sequence Number: 17875174
• Product Code: NAY
• UDI-Device Identifier: 00886874113639
• UDI-Public: (01)00886874113639(10)N10181105
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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: 478059-04
• Device Catalogue Number: 478059
• Device Lot Number: N10181105 0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2018
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian