MAUDE Adverse Event Report: LEXINGTON MEDICAL AEON ENDOSCOPIC STAPLER; IMPLANTABLE STAPLE

Model Number	AESR60R
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An aeon endostapler 3.25mm/60mm orange reload was used with an aeon endostapler handle medium in a low anterior resection procedure by the physician on (b)(6) 2022.The physician fired the reload across the first staple line at full articulation.The physician noted high force and heard a crack sound from the handle.The retraction knob was then unable to be pulled back and the reload remained clamped on the tissue.The reload was removed by stapling/cutting.Surgery was delayed by more than 30 minutes.No patient harm.
Additional Manufacturer Narrative
Root cause: after investigation, it was determined that the level one root cause for the inability to fully retract and unclamp the reload was that the blade assembly was bent.The level two root cause may have been attributed to high firing forces in over-indicated tissue thickness conditions.This was evidenced by the multiple broken rack teeth within the handle.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: AEON ENDOSCOPIC STAPLER
• Common Device Name: IMPLANTABLE STAPLE
• Manufacturer (Section D): LEXINGTON MEDICAL; 23 crosby drive; bedford MA 01730
• Manufacturer Contact: rainer maas ; 23 crosby druve; bedford, MA 01730 ; 6172099817
• MDR Report Key: 14018387
• Report Number: 3012998149-2022-00001
• Device Sequence Number: 11915518
• Product Code: GDW
• UDI-Device Identifier: 00851574008677
• UDI-Public: (01)00851574008677
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

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 Model Number: AESR60R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AEON ENDOSCOPIC STAPLER HANDLE - MEDIUM (AESH160)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown