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

Model Number	EEA2135
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic assisted distal gastrectomy, the first device was use in gastrojejunostomy and the second device in jejunojejunostomy.The surgeon felt that the handle became more stiff than usual.It was impossible to squeeze the handle to get reach to the main body as usual use.After procedure, they reset the anvil and confirmed that the handle was still very stiff.A strong resistance was felt when there was at about 1.5 cm to complete the squeezing.There was no patient injury.

• Brand Name: EEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8179586
• Report Number: 2647580-2018-06184
• Device Sequence Number: 11196047
• Product Code: GDW
• UDI-Device Identifier: 10884523004724
• UDI-Public: 10884523004724
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2018

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: 06/30/2023
• Device Model Number: EEA2135
• Device Catalogue Number: EEA2135
• Device Lot Number: P8F1216KX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1