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

Catalog Number	B12SRT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 10/15/2024.D4: batch # c9dw3l.Investigation summary : the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the b12srt device was received with the duckbill out of position and returned inside a plastic bag.In addition, the tyvek was returned along with the instrument.No conclusion could be reached as to what might have caused the duckbill out of position.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during laparoscopic gastrectomy, when a silicone disc was inserted through the 12mm port, the valve inside deviated into the abdominal cavity.The part was immediately retrieved, but the port could not be repaired outside the body, and an additional port was eventually used.The device was used on abdominal wall.There was no bleeding.No pieces were left inside the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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 ; * 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: 20452085
• Report Number: 3005075853-2024-07758
• Device Sequence Number: 8616573
• Product Code: GCJ
• UDI-Device Identifier: 10705036001188
• UDI-Public: (01)10705036001188(17)290331(10)954C13
• 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
• Report Date (Section B): 10/15/2024

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: B12SRT
• Device Lot Number: 954C13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown