MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. SNAP-YT 15 DEGREES BLUE BLADE; ENDOSCOPIC INSTRUMENT ACCESSORY

Model Number 400152-02

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) will not be receiving the 15 degree blue blade as it was discarded.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) of if additional information is received.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the 15 degree blue blade fell inside the patient and was retrieved.There was no report of patient harm, adverse outcome or injury, however, it is unknown what caused the 15 degree blue blade to fall inside the patient.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the 15 degree blue blade fell off from the snap fit scalpel instrument and into the patient.The missing blade was detected by x-ray and removed from the patient's abdomen during the same procedure.There was no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) made multiple follow up attempts and obtained the following additional information: the customer confirmed the 15 degree blue blade was discarded and will not be returned to isi.

• Brand Name: SNAP-YT 15 DEGREES BLUE BLADE
• Type of Device: ENDOSCOPIC INSTRUMENT ACCESSORY
• 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: 6912471
• MDR Text Key: 88129494
• Report Number: 2955842-2017-00649
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400152-02
• Device Lot Number: AAAJ262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1