MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC DEXTRUS SEAL CAP ASSEMBLY/ SEAL CAP ASSEMBLY WITH ACCESSON; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Lot Number	R94N9N
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Opened a dexrus seal cap assembly to use during surgery and the device had a hole in it.Had to get a new one.Kept device and turned it in to management.

• Brand Name: DEXTRUS SEAL CAP ASSEMBLY/ SEAL CAP ASSEMBLY WITH ACCESSON
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; guaynabo PR 00969
• MDR Report Key: 8343253
• Report Number: MW5084085
• Device Sequence Number: 1915421
• Product Code: GCJ
• UDI-Device Identifier: 10705036002055
• UDI-Public: (01)10705036002055
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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: 09/30/2020
• Device Lot Number: R94N9N
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 99