MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG ENDO PEANUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	173019
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the laparoscopic cholecystectomy procedure the swab part of the device disengaged into the patient and was immediately retrieved by the physician.To complete the procedure, a new device was used.There was no harm caused to the patient.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The cotton tip was firmly attached to the returned endo peanut device.A review of the device history record indicates that, although, the product was released meeting all quality release specifications at the time of manufacture, a field action and a corrective and preventative action have been initiated for this product which includes this particular lot.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO PEANUT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6536621
• Report Number: 1219930-2017-05429
• Device Sequence Number: 19053742
• Product Code: GCJ
• UDI-Device Identifier: 20884523000761
• UDI-Public: 20884523000761
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K931962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2018

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: 01/31/2022
• Device Model Number: 173019
• Device Catalogue Number: 173019
• Device Lot Number: M7A01X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 12/15/2017; 01/10/2018
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 01/10/2018; 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1