MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	B5ST
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, a foreign matter like a bug was inside before the package was opened.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/28/2023 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: (b)(6) 2024 d4: batch # unk investigation summary the product was returned to lab cincinnati for evaluation.Visual inspections were conducted on the returned device.Visual analysis of the returned sample determined that the b5st device was returned inside its package unopened; upon visual inspection, a foreign matter was noted to be inside the packaging and appears to be cardboard box.The device was inspected, and the particle was photographed (image 1).The material was analyzed using fourier transform infrared spectrometer (ftir), which can identify the composition of a polymer by passing an infrared beam into the material and measuring the wavelength of the light absorbed by the material.Particle 1 was identified as cardboard with silicone (spectrum 1).Cardboard is used at all levels of packaging.Silicone is used on the device and could have transferred to the cardboard particle in the package, it is also possible that the cardboard particle was coated with silicone before it got into the packaging.Although no conclusion could be reached on how the cardboard box was introduced inside the sterile package, it is possible that the cardboard box adhered to the device during the packaging process due to static.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4) date sent: (b)(6) 2024 d4: batch # unk device evaluation is pending.A manufacturing record evaluation is pending.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• 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: 18409825
• Report Number: 3005075853-2023-09933
• Device Sequence Number: 2932398
• Product Code: GCJ
• UDI-Device Identifier: 10705036001232
• UDI-Public: 10705036001232
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2024

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: B5ST
• Device Lot Number: 576C25
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 01/25/2024; 03/20/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 02/13/2024; 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown