MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. TIP COVER ACCESSORY; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 400180

Device Problems Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 09/06/2017

Event Type  malfunction  

Event Description

Tip cover used to protect robotic instrument during procedure came off in place for the majority of the procedure.Surg tech noted it missing when removed from the abdominal cavity.Surgeon informed.Laparoscopic search conducted, transition to hand-assisted laparoscopic, then conversion to open laparotomy to facilitate thorough cavity search.Radiology films taken and reviewed by radiologist prior to conversion to open.Tip cover not visualized on the film.Film taken of a new tip cover to provide comparison for radiologist.Tip cover not radiopaque.After tip cover reported missing, a thorough search of the room, trash and linen conducted.Abdominal ap and lateral x ray was performed and read by the on duty radiologist after which more intra-abdominal and pelvic searching was performed.At the discretion of the surgeon, searching was discontinues and the abdomen was closed.All other surgical counts were performed per policy and found to be correct.It was retrieved from the subcutaneous tissue in a separate procedure.

• Brand Name: TIP COVER ACCESSORY
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd; sunnyvale CA 94086
• MDR Report Key: 6993617
• MDR Text Key: 90785541
• Report Number: 6993617
• 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: 09/19/2017,10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 400180
• Device Lot Number: M10170621
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 37 YR