MAUDE Adverse Event Report: CONMED CORPORATION CONMED REFLEX ONE SKIN STAPLER; STAPLER, SURGICAL

Catalog Number	8035
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Skin stapler malfunctioned.Trigger was pulled once and two staples came out.The first one embedded into the skin properly, and the second one went in on one side only.Fda safety report id #: (b)(4).

• Brand Name: CONMED REFLEX ONE SKIN STAPLER
• Common Device Name: STAPLER, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13502
• MDR Report Key: 10244956
• Report Number: MW5095417
• Device Sequence Number: 10883825
• Product Code: GAG
• UDI-Device Identifier: 00653405036923
• UDI-Public: (01)00653405036923
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/04/2020

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: 01/30/2024
• Device Catalogue Number: 8035
• Device Lot Number: 201901314
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 46