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); Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Date of event: date of event is 2020.Event day and month were not reported.Investigation summary: the analysis results found that the pn150 device was returned inside its original package.Upon visual inspection, it was noted that the tyvek was delaminated possible causes of tyvek delamination are tyvek quality or seal strength; however, no conclusion could be reached as to what may have caused this condition.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during an unknown procedure, the package was falling apart and degrading as it was opened, compromising the device sterility.There were no patient consequences.No additional information is available at this time.

• Common Device Name: APPARATUS, PNEUMOPERITONEUM, AUTOMATIC
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 10444481
• Report Number: 3005075853-2020-04280
• Device Sequence Number: 2713902
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2020

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: 09/30/2022
• Device Model Number: PN150
• Device Catalogue Number: PN150
• Device Lot Number: P4T44K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/24/2020
• Patient Sequence Number: 1