MAUDE Adverse Event Report: ETHICON SURGERY,ENDO- LLC PROXIMATE; STAPLE, IMPLANTABLE

Model Number	TX30V
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Early 50¿s male with acute appendicitis.Procedure: laparoscopic appendectomy converted to open.The ethicon stapler would not fire.Another device used.No known harm to patient that was discharged the next day. = manufacturer response for staple, implantable, proximate (per site reporter). = will obtain.

• Brand Name: PROXIMATE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON SURGERY,ENDO- LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 14955637
• Report Number: 14955637
• Device Sequence Number: 12136868
• Product Code: GDW
• UDI-Device Identifier: 10705036003335
• UDI-Public: (01)10705036003335(17)240430(10)T40H0W
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/30/2022
• Report Date (Section F): 06/30/2022

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 Model Number: TX30V
• Device Catalogue Number: TX30V
• Device Lot Number: T40H0W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 155 KG
• Date Report Sent to FDA: 06/30/2022