MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. TIP-UP FENESTRATED GRASPER

Model Number 470347

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The instrument has not be returned to isi for failure analysis; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is received.Based on the provided information, this complaint is being reported due to the following conclusion: during a da vinci assisted surgical procedure, it was alleged that broken fragments fell inside the patient.Although, the broken fragments were retrieved without patient harm, at this time it is unknown what caused the breakage to occur.

Event Description

It was reported that during a da vinci-assisted sigmoid colectomy procedure, as the surgeon was getting ready to convert the procedure to laparoscopy, the tip-up fenestrated grasper instrument could not be removed from the cannula accessory as it could not be straightened out.The surgeon observed a broken piece of the instrument shaft on the bowel and frayed wires.The robotics coordinator was then called into the room and was unable to remove the instrument without completely breaking the instrument.The shaft of the instrument was falling apart in her hand and she placed the pieces in a cup for evaluation.According to the surgeon, all pieces were removed.There was no report of patient harm, adverse outcome or injury.On (b)(6) 2018, intuitive surgical, inc.(isi) made a follow-up attempt to obtain additional information; however, the customer could not release any other information.Furthermore, it was confirmed that the instrument was sequestered and that it was stuck in a 8mm cannula accessory and could not be removed without breaking the instrument completely.

• Brand Name: TIP-UP FENESTRATED GRASPER
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 7227232
• MDR Text Key: 98973641
• Report Number: 2955842-2018-00064
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470347
• Device Lot Number: N10170508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR