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

Catalog Number	PN120
Medical Device Problem Code	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 robotic procedure, the safety needle remained exposed after puncture and did not retract.Opened a second product to complete case.No patient harm.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/2/2024.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.During the visual inspection, the tip of the needle was noted with dried body fluids.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 434a28 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: 20351135
• Report Number: 3005075853-2024-07426
• Device Sequence Number: 18155910
• Product Code: FDP
• UDI-Device Identifier: 10705036012962
• UDI-Public: (01)10705036012962(17)260831(10)434A28
• 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): 10/02/2024

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 Expiration Date: 08/31/2026
• Device Catalogue Number: PN120
• Device Lot Number: 434A28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown