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

Model Number	EEAXL2835
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
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, when the device was being applied to end to end anastomosis during a laparoscopic colectomy, it was stated that the anvil prematurely tilted when seating center spike prior to firing stapler.A new stapler anvil was used to complete the case.There as no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the staple guide noted the presence of a full complement of staples.The anvil of the instrument was observed to be tilted, separated from the instrument, and part of the crush ring was observed to be crushed.The retainer leg of the anvil was observed to be bent.Due to the observed damage on the received anvil, a pmv representative anvil was used for functional testing.The device was applied over the appropriate test media producing acceptable results.The knife cut the test media cleanly and completely and the staple line was properly formed.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 anvil tilting prior to firing may occur if the device is closed over an excessive amount of tissue which compresses the crush ring.The root cause of the observed damage was due to the product not being used as indicated which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.Additionally, the investigation detected a unreported condition of a bent anvil retainer leg that has no relationship to the reported condition.If information is provided in the future, a supplemental report will be issued.

• 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: 9455650
• Report Number: 2647580-2019-06068
• Device Sequence Number: 3072625
• Product Code: GDW
• UDI-Device Identifier: 10884523006148
• UDI-Public: 10884523006148
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

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: 02/29/2024
• Device Model Number: EEAXL2835
• Device Catalogue Number: EEAXL2835
• Device Lot Number: P9C1489KY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1