MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS PREMIUM PLUS CEEA; STAPLE, IMPLANTABLE

Model Number	111981
Medical Device Problem Codes	Difficult to Open or Close (2921); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The device displayed nicks on the knife blade.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Replication of the observed knife blade damage may occur if the instrument is applied over an obstruction.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.The information booklet cautions the user to make certain the section of the tissue to be stapled is free from any metal clips or similar structures; otherwise, the knife blade may not cut.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open procedure of low anterior resection, the device was difficult or unable to close.Unusual effort was needed to turn the twist knob in order to visualize the green bar.The patient had no injury.

• Brand Name: PREMIUM PLUS CEEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 7332716
• Report Number: 3006451981-2018-00178
• Device Sequence Number: 147944
• Product Code: GDW
• UDI-Device Identifier: 10884523006575
• UDI-Public: 10884523006575
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2018

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: 09/08/2021
• Device Model Number: 111981
• Device Catalogue Number: 111981
• Device Lot Number: S6JC006X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 69