MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; CADIERE FORCEPS

Model Number	478055-04
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to the patient being hepatitis positive, the site will not be returning the instrument to isi 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.Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the plastic part of the wrist from a cadiere forceps instrument broke and fell inside an infected patient.A backup instrument was used to continue.All fragments were retrieved and no additional surgical intervention was required.However, unintended fragment(s) falling into the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the plastic part of the wrist from a cadiere forceps instrument broke and fell inside a patient who was infected.The fragment was retrieved during the same procedure.A backup instrument was used to continue.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 hepatitis positive.The customer retrieved the fragment from the patient immediately using a da vinci forceps.All fragments were retrieved with no additional surgical procedure required.The instrument was inspected prior to use.The surgeon did not notice any issue with the functionality of the instrument during the surgical procedure.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.The wrist was straightened upon the final removal of the instrument.The surgical staff did not feel any resistance upon the removal of the instrument through the cannula.The surgical staff did not notice any damage to the cannula or 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.
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.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: SINGLE-SITE
• Common Device Name: CADIERE FORCEPS
• 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: 9827477
• Report Number: 2955842-2020-10186
• Device Sequence Number: 11368124
• Product Code: NAY
• UDI-Device Identifier: 00886874113608
• UDI-Public: (01)00886874113608(10)N10190909
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2020

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: 478055-04
• Device Lot Number: N10190909 0003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2020
• Supplement Date Received by Manufacturer: 02/16/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• 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
• 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