MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. DEXTRUS SEAL CAP ASSEMBLY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	HAP02
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.As a lot/batch was not provided, a device history could not be performed.
Event or Problem Description
Device breakage.Opened the packing, noted the seal was damaged.Another device was used to complete the surgery.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: DEXTRUS SEAL CAP ASSEMBLY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7978042
• Report Number: 3005075853-2018-13690
• Device Sequence Number: 11111245
• Product Code: GCJ
• UDI-Device Identifier: 10705036002055
• UDI-Public: 10705036002055
• Combination Product (Y/N): N
• PMA/510(K) Number: K070198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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 Catalogue Number: HAP02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/16/2018
• Patient Sequence Number: 1