MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*PNEUMOPERITONEUM NDL

Model Number	PN150
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.
Event or Problem Description
It was reported that during an unknown procedure, the needle of pn150 penetrated the package.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/23/2022 investigation summary the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that pn150 device was returned inside it's original packaging.Upon visual inspection, it was observed that the pouch from the packaging was damaged; it was noted to have a hole in the pouch, the hole was noted to be from the inside out.The hole was located at the needle, the needle perforated the pouch due to wrong placement of the red tip protector cap.The sterility was compromised.All ethicon product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reach on the cause of the reported event as per conditions of the returned device.

• Common Device Name: ENDOPATH*PNEUMOPERITONEUM NDL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo
• MDR Report Key: 14337624
• Report Number: 3005075853-2022-02975
• Device Sequence Number: 17448406
• Product Code: FDP
• UDI-Device Identifier: 10705036012979
• UDI-Public: 10705036012979
• Combination Product (Y/N): N
• PMA/510(K) Number: K910875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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 Expiration Date: 08/31/2026
• Device Model Number: PN150
• Device Catalogue Number: PN150
• Device Lot Number: 449A97
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown