MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*PROBE PLUS II HANDLE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	EPH02
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: does the damage to the package compromise the sterility of the device? yes- when the box falls from the shelf, the sterility may be compromised.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during an unknown procedure the box for this product as a dispenser is not working.The box is flimsy.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/4/2021.This is an evaluation of an image sent by the account.Image: the image provided shows devices into the box packing, it seems to be with the tyvek and the blister bent.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.No conclusion could be reached as to the root cause of the reported issue.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12197814
• Report Number: 3005075853-2021-04022
• Device Sequence Number: 3036235
• Product Code: GCJ
• UDI-Device Identifier: 10705036012443
• UDI-Public: 10705036012443
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K912492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: EPH02
• Device Catalogue Number: EPH02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/25/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/04/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.; GENERATOR