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

Catalog Number	PN150
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being 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.
Event or Problem Description
It was reported that prior to an unknown procedure, the packaging showed signs of disintegration.There was no patient consequence.

• Common Device Name: APPARATUS, PNEUMOPERITONEUM, AUTOMATIC
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9485420
• Report Number: 3005075853-2019-24517
• Device Sequence Number: 10857682
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2019

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: 01/01/2021
• Device Catalogue Number: PN150
• Device Lot Number: N4L604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/17/2019
• Patient Sequence Number: 1