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

Model Number	173019
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during surgery, the tip of the device came off and fell into the patient's cavity.It was immediately retrieved.Procedure was completed with a different device.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one endo peanut 5mm device.Pmv observed that the cotton swab had disengaged from one of the shafts.No sign of adhesive or sheared cotton swab material was observed on the distal end of that shaft where the swab was affixed.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, an assembly error was identified during product analysis.The most probable root cause of the condition maybe due to an inadequate amount of adhesive in affixing cotton tip.A process improvement has been implemented to prevent this condition from recurring.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 LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7114620
• Report Number: 1219930-2017-09923
• Device Sequence Number: 1379014
• Product Code: GCJ
• UDI-Device Identifier: 20884523000761
• UDI-Public: 20884523000761
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2018

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: 07/31/2022
• Device Model Number: 173019
• Device Catalogue Number: 173019
• Device Lot Number: M7G02X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 12/20/2017; 02/14/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/17/2018; 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1