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

Model Number	478059-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The crocodile grasper instrument had not been returned to isi for evaluation.Therefore, the root cause of the customer reported issue cannot be determined.If additional information is received, a follow-up mdr will be submitted to the fda.Based on the information provided at this time, this complaint is being reported because one of the crocodile grasper instrument's jaws fell inside the patient.The fragment was retrieved during the same procedure and no additional surgical intervention was required.However, unintended fragment falling into the patient may require surgical intervention.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, one of the jaws of the crocodile grasper instrument broken off and fell into the patient.The customer retrieved the fragment and used a backup instrument.The procedure was completed as planned with no injury to the patient.On (b)(6) 2020, isi followed up with the initial reporter and obtained additional information.The instrument was in use for one minutes when the fragment came off.A second crocodile grasper instrument was used to retrieve the fragment during the same procedure.The instrument was inspected prior to use and did not make contact with any other instruments or hard material during the surgical procedure.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1 b1 updated from "product problem" to "adverse event and product problem" b2 updated to "required intervention" h1 updated from "malfunction" to "serious injury".

• Brand Name: SINGLE-SITE
• Common Device Name: CROCODILE GRASPER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 9742354
• Report Number: 2955842-2020-10135
• Device Sequence Number: 16233535
• Product Code: NAY
• UDI-Device Identifier: 00886874113639
• UDI-Public: (01)00886874113639(10)N10180719
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 478059-03
• Device Lot Number: N10180719 0047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 26 YR
• Patient Sex: Female