MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOPATH DEXTRUS; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	HAP02
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon asked for wound protector (dextrus seal cap assembly).Item was located and opened and found to be broken.An additional wound protector was in the room and opened as a replacement.

• Brand Name: ENDOPATH DEXTRUS
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 20694399
• Report Number: 20694399
• Device Sequence Number: 6583622
• Product Code: GCJ
• UDI-Device Identifier: 10705036002055
• UDI-Public: (01)10705036002055
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/12/2024
• Report Date (Section F): 09/12/2024

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: HAP02
• Device Catalogue Number: HAP02
• Device Lot Number: (10)X94X2X
• 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: 11/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 42 KG
• Date Report Sent to FDA: 09/12/2024