MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. HARMONIC ACE; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Catalog Number 480275

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

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

Event Date 09/20/2017

Event Type  malfunction  

Event Description

During intraop the da vinci harmonic instrument tip broke off in the patient while in use.The broken tip was retrieved and the instrument was removed immediately.The broken tip aligned with instrument to make sure all parts were retrieved.No harm was visible noted to patient.

• Brand Name: HARMONIC ACE
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 7024722
• MDR Text Key: 91821209
• Report Number: 7024722
• 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: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: 480275
• Device Lot Number: M10170619
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR