MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA; STAPLE, IMPLANTABLE

Model Number EEA2535

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during sigmoidectomy, the surgeon anastomosed the tissue and rotated the twist knob twice, then the surgeon tried to remove the device from the patient, however could not.The surgeon rotated the knob and tried to remove it once more and it was removed but the anvil was disengaged from the instrument and fell in the intestinal canal.It was removed using a kelly dissector.No leakage during leak test.The surgeon constructed the covering stoma just to be sure.There was no patient injury.

Manufacturer Narrative

Additional information: (expiration date).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: during sigmoidectomy, the surgeon anastomosed the tissue and rotated the twist knob twice, then the surgeon tried to remove the device from the patient, however could not.The surgeon rotated the knob and tried to remove it once more and it was removed but the anvil was disengaged from the instrument and fell in the intestinal canal.It was removed using a kelly dissector.No leakage during leak test.The surgeon constructed the covering stoma just to be sure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the device under the microscope displayed nicks on the knife blade.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 instructions for use manual for this product states that to make certain that the section of tissue to be stapled is free from any metal or similar structure; otherwise, the knife blade may not cut.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EEA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7664760
• MDR Text Key: 113282919
• Report Number: 2647580-2018-03355
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523004748
• UDI-Public: 10884523004748
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: EEA2535
• Device Catalogue Number: EEA2535
• Device Lot Number: P7L1311KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1