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

Model Number	111981
Medical Device Problem Codes	Difficult to Remove (1528); Misfire (2532)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348)
Date of Event	03/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during an open sigmoidectomy procedure with dst anastomosis.When the surgeon tried to pull the device out after firing it, the anvil caught up and the device could not be removed from the stapling site.The surgeon pulled it several times, the device got out but the anvil remained in the intestinal tract.The device was removed from the tissue by force but no tissue damage was caused.The surgeon attempted to pull out the anvil but could not withdraw it.Resected the mouth side and thenal side tissue additionally and performed anastomosis again used a new product.Additional tissue resection was required due to the tissue.There was tissue damage.When examining the specimens that were taken out, the tissue was cut for two-thirds, but one-third was uncut.The surgical time was extended by less than thirty minutes.The status of the patient is no problem.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The event report alleges the product was used in a procedure.Inspection under the microscope displayed nicks on the knife blade.The instrument was applied to the appropriate test media producing acceptable results, despite the noted knife blade damage.Records from each manufacturing lot are thoroughly reviewed to ensure that products are 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.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.A good faith effort will be made to obtain the applicable information relevant to the report.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: 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: 6452869
• Report Number: 3006451981-2017-05111
• Device Sequence Number: 10981725
• Product Code: GDW
• UDI-Device Identifier: 10884523006575
• UDI-Public: 10884523006575
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062850
• 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): 04/10/2017

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: 07/31/2020
• Device Model Number: 111981
• Device Catalogue Number: 111981
• Device Lot Number: S5GC006X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided; 04/10/2017
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 05/04/2017; 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: Other