MAUDE Adverse Event Report: INTUITIVE SURGICAL INC HARMONIC ACE CURVED SHEARS INSERT

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

Reported to risk on (b)(6) 2015 the following: harmonic ace curved shears insert tip broke off inside pt during robotic assisted laparoscopic cholecystectomy.Instrument was removed, replaced, and broken tip was retrieved from inside pt.No harm to pt.Instrument removed from room and taken to evening supervisor, wrapped in plastic, and labeled.Talked to or mgr and she did not have the broken instrument.Unable to find anything else on this event.Being reported as a pt safety concern.This is the only info forwarded to me on the equipment: harmonic ace curved shears insert.Ref: 400(b)(4)272.Possible case lot # m1041120 by intuitive surgical with an expiration date 11/01/2016.

• Brand Name: HARMONIC ACE CURVED SHEARS INSERT
• Type of Device: HARMONIC ACE CURVED SHEARS INSERT
• Manufacturer (Section D): INTUITIVE SURGICAL INC; 1020 kifer rd; sunnyvale CA 94086
• MDR Report Key: 4627460
• MDR Text Key: 5660091
• Report Number: 4627460
• Device Sequence Number: 1
• Product Code: NAY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Other Device ID Number: REF # 400272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2015
• Distributor Facility Aware Date: 02/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR