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	Radiation Exposure, Unintended (3164); No Information (3190)
Date of Event	02/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter: during the procedure, the white cotton swab at the tip of the instrument disengaged into the patient cavity.To correct this issue, the disengaged component was retrieved from the patient cavity.Surgical time was extended for 30 minutes or more.X-ray was done to find the disengaged component.
Event or Problem Description
According to the reporter: during a lap chole procedure, the white cotton swab at the tip of the instrument disengaged into the patient cavity.To correct this issue, the disengaged component was retrieved from the patient cavity.Surgical time was extended for 30 minutes or more.X-ray was done to find the disengaged component.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of three endo peanut.Evaluation confirmed the cotton tip was detached from all of the devices with no evidence of adhesive.A review of the device history record indicates this product was released meeting all medtronic quality release specifications at the time of manufacture.However, an assembly error was identified during product analysis.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.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
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: 6416888
• Report Number: 1219930-2017-05102
• Device Sequence Number: 34780
• Product Code: GCJ
• UDI-Device Identifier: 20884523000761
• UDI-Public: 20884523000761
• 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,Followup,Followup,Followup
• Report Date (Section B): 04/17/2017

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: 09/30/2021
• Device Model Number: 173019
• Device Catalogue Number: 173019
• Device Lot Number: M6J04X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 04/17/2017
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 04/04/2017; 05/17/2017; 10/02/2017
• 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: 63 YR
• Patient Weight: 84