MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. SNAP-FIT PADDLE BLADE ACCESSORY; ENDOSCOPIC INSTRUMENT ACCESSORY

Model Number 400158-01

Device Problems Component Falling (1105); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2014

Event Type  malfunction  

Event Description

It was reported that the during a da vinci hysterectomy procedure, the snap-fit paddle blade fell off the tip and got dislodged into the fibroid.The blade was removed and the planned surgical procedure was completed by replacing the blade.The surgeon believes that the blade had become dull, causing it to fall off.On (b)(4) 2014, intuitive surgical, inc.Contacted the clinical sales rep (csr) to obtain additional information regarding the reported complaint.The csr indicated that the blade was being used to debulk the fibroids on the uterus.The blade was retrieved laparoscopically through the assistant port.The instrument and blade were inspected prior to use and no physical damage was observed.No additional surgical procedure was required to retrieve the blade.No post-operative test were required and no injury to the patient occurred.

Manufacturer Narrative

The csr indicated that the snap-fit paddle blade will not be returned for evaluation.The root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is received.This complaint is being reported due to the following conclusions: the snap-fit paddle blade got dislodged into the fibroids during a da vinci hysterectomy procedure.The blade was retrieved laparoscopically.No additional surgical procedure or post-operative test were required to retrieve the blade.There was no allegation patient injury or adverse event.

• Brand Name: SNAP-FIT PADDLE BLADE ACCESSORY
• 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 94086
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 3793869
• MDR Text Key: 4385518
• Report Number: 2955842-2014-02820
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K990144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400158-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1