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

Model Number	PN150
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic procedure two of the devices' tyvek packaging flaked when peeled and fell onto the table raising sterility concerns.A new device from a different lot was opened with no issues.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/13/2023.D4: batch # unknown.Investigation summary : the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that two pn150 devices were returned inside it's unopened.Upon visual inspection of the tyvek, was confirmed to be damaged; it was noted to have flakes loose from the tyvek.Although no conclusion could be reached on how these white flakes get loose from the tyvek.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device lot u40n1m number, and no non-conformances were identified.

• Common Device Name: APPARATUS, PNEUMOPERITONEUM, AUTOMATIC
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17319808
• Report Number: 3005075853-2023-04909
• Device Sequence Number: 6188080
• Product Code: FDP
• UDI-Device Identifier: 10705036012979
• UDI-Public: 10705036012979
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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: 09/30/2025
• Device Model Number: PN150
• Device Catalogue Number: PN150
• Device Lot Number: U40N1M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown