MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST NEEDLE DRIVER; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 420117

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2017

Event Type  malfunction  

Event Description

One cable bent, no peel pack found.Surgeon refused to open a second tray so procedure was converted to laparoscopic.Manufacturer response for 5mm needle driver, (brand not provided) (per site reporter): vendor to send rma for return.

• Brand Name: ENDOWRIST NEEDLE DRIVER
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; mario lowe; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 6810056
• MDR Text Key: 83226783
• Report Number: 6810056
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 420117
• Device Lot Number: S11151110 509
• Other Device ID Number: 5MM NEEDLE DRIVER
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1