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

Catalog Number	PN120
Medical Device Problem Codes	Improper Flow or Infusion (2954); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the pneumoneedle was inserted into the incision site, but the spring did not work as intended to give physical feedback of abdominal layers.No patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/22/2024.D4: 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/4/2025.D4: batch # unk.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the pn120 device was returned with no apparent damage.In addition, the tyvek was returned along with the instrument.During the visual inspection, no anomalies were noted on the tip of the needle.The device was functionally tested to detect any issues.Upon evaluation of the device, it was functionally tested and passed.The device was fully functional according to the manufacturing requirements.Although no conclusion could be reach on the cause of the reported event, the instructions for use do contain the following caution: during insertion, inspect the instrument handle to ensure that the ¿red safety indicator¿ slides proximally in the direction of the stopcock.This action retracts the blunt stylet and exposes the sharp needle tip for penetration.Do not attempt to use the endopath pneumoneedle if the blunt stylet does not retract into the needle sleeve.Once the blunt stylet is free of tension from the tissue, the ¿red safety indicator¿ resets itself back into the distal portion of the handle.Use appropriate testing to ensure that the endopath pneumoneedle is safely in the abdominal cavity.Once testing is completed, insufflate the abdomen.The event described could not be confirmed as no damages were observed and the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device lot 721c34 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20508005
• Report Number: 3005075853-2024-07954
• Device Sequence Number: 9044500
• Product Code: FDP
• UDI-Device Identifier: 10705036012962
• UDI-Public: (01)10705036012962(17)281031(10)721C34
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/04/2025

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: 721C34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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