MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ENDO PEANUT* 5MM DEVICE (3 PER PACK); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	173019
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional attempts to obtain information and the device have been made.A supplemental report will be submitted with new details if they become available.
Event or Problem Description
According to the reporter, the tip came off during non-active use.No device fragment fell into the patient.

• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• MDR Report Key: 5886223
• Report Number: 1219930-2016-00881
• Device Sequence Number: 11119302
• Product Code: GCJ
• UDI-Device Identifier: 10884523000764
• UDI-Public: (01)10884523000764
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K931962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 173019
• Device Catalogue Number: 173019
• Device Lot Number: M6B01X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2016
• Initial Report FDA Received Date: 08/18/2016
• Patient Sequence Number: 1