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

Model Number	478055-02
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	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cadiere forceps has not been returned for analysis.Therefore, the root cause of the customer reported failure cannot be determined.If additional information is received, a follow up mdr will be submitted.Based on the information at this time, this complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, fragments from the cadiere forceps broken off and fell inside the patient.Although, the fragments were retrieved without patient harm, 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 total benign hysterectomy surgical procedure, the instrument "exploded" and fragments fell inside the patient.The instrument was not grasping tissue at the time.The fragments were retrieved during the same procedure.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer to confirm that the cadiere forceps instrument and cannula were inspected prior to use.The instrument had been inserted for the first time during the procedure and the surgeon was in the process of turning the instrument to orient it when it broke.The instrument did not come into contact with any hard material.At the end of the procedure, an x-ray was performed to locate the fragments.All fragments were located and removed with laparoscopic instruments during the same procedure.The patient has not experienced any post-operative complications.
Additional Manufacturer Narrative
61 - the cadiere forceps had the ear of the distal clevis broken.The broken piece was roughly.189 inches by.345 inches in size.This failure is most commonly caused by overloading the instrument tip.The clevis rivet pin was also dislodged as a result of the clevis breakage.The clevis pin was returned with the instrument.The known common cause of this failure is due to mishandling/misuse.The instrument was found to have the grips dislodged as a result of the clevis breakage.Both grips were returned with the instrument and had no missing material.

• Brand Name: SINGLE-SITE
• Common Device Name: CADIERE FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 8402066
• Report Number: 2955842-2019-10170
• Device Sequence Number: 13531088
• Product Code: NAY
• UDI-Device Identifier: 00886874113608
• UDI-Public: (01)00886874113608(10)S10170425
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K152448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 478055-02
• Device Lot Number: S10170425 0058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES