MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PREMIUM PLUS CEEA; STAPLE, IMPLANTABLE

Model Number	111983
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Form Staple (2579)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter; during an esophagectomy procedure, after the doctor fired the device to anastomose the esophagus and gastric tube, the doctor remove the device from the tissue much difficulty.He found one hole near the part of anastomosis.The doctor sutured to complete the surgery.There was no issue with the patient after the case.There was no patient injury, medical intervention, or extension of surgical time by 30min or more.Current patient status is stable.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.A microscope examination of the device displayed nicks on the knife blade and cross cutting staple line marks were observed along the cutline impression in the cutting ring.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 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.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 amended as appropriate.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): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 6427197
• Report Number: 2647580-2017-05137
• Device Sequence Number: 10897009
• Product Code: GDW
• UDI-Device Identifier: 20884523006589
• UDI-Public: 20884523006589
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K001895
• 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
• Report Date (Section B): 12/19/2017

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: 06/30/2019
• Device Model Number: 111983
• Device Catalogue Number: 111983
• Device Lot Number: P4F0055X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 12/19/2017
• 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