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	Tissue Damage (2104); Injury (2348); Radiation Exposure, Unintended (3164)
Date of Event	02/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter during a laparoscopic hernia procedure, the end of the peanut fell into the patient cavity.X ray was performed to locate and retrieve the component.There was tissue damage as a result of this problem.The tubes were damaged and required suture repair.The damage was not permanent.Surgical times was extended by 90 minutes.Current patient status is alive with injury.There was no unanticipated tissue loss.There was no blood loss of 500cc or more.There was no extension of incision due to the product problem.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of three devices.The event report alleges the product was used in a surgical procedure.The cotton tip was detached from device one with no evidence of adhesive.The root cause of the observed condition was determined to be a result of an inadequate amount of adhesive on the device; this was identified as a quality issue with a component obtained from a third party supplier and a product enhancement has been initiated to track this failure mode and/ complaint mode.Based on the evidence available the reported condition was confirmed.The file will be closed as an assembly error.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 LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 6404202
• Report Number: 1219930-2017-05081
• Device Sequence Number: 10991338
• Product Code: GCJ
• UDI-Device Identifier: 20884523000761
• UDI-Public: 20884523000761
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K931962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 173019
• Device Catalogue Number: 173019
• Device Lot Number: M6F01X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: 07/24/2017; 07/24/2017
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 08/22/2017; 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR