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

Catalog Number	PN120
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/11/2024 d4: batch # unk 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 the pn120 device was returned inside it's package unopened; upon visual inspection, a foreign matter was noted to be inside the packaging and appears to be flash from the device.The package was visually inspected and no damaged was observed.During manufacturing/testing in some cases, component friction can result in small shavings ejecting from the device after packaging during transit.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that pre procedure, it was noticed that there was a hole in the bag, rendering it nonsterile.Case completed with like device.No patient consequences.

• 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: 19512849
• Report Number: 3005075853-2024-04295
• Device Sequence Number: 19724341
• Product Code: FDP
• UDI-Device Identifier: 10705036012962
• UDI-Public: 10705036012962
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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: PN120
• Device Lot Number: 871C93
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown