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

Catalog Number B12SRT

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 4/4/2024.D4: batch # a9dd1x.Additional information was requested and the following was obtained: "the duckbill valve fell into the patient was retrieved through the 12mm port.There was no additional wound for to retrieve the duckbill valve.The patient is stable after the operation.The duckbill valve will be returning with the device." 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 present.In addition, the universal seal and duckbill were returned inside a plastic bag.No conclusion could be reached as to what might have caused the duckbill out of position.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during a laparoscopic gastrectomy, it was noticed that the intraperitoneal pressure was not kept constant 30 minutes after the operation was started.Then noticed that the duckbill valve was missing.The duckbill valve had fallen into the patient abdomen.The duckbill valve was retrieved.There was a strong resistance when lapdisc for to compress the liver was inserted, so there is a possibility that the duckbill valve fell off at that time.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
• Type of Device: 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: 19047042
• MDR Text Key: 339615588
• Report Number: 3005075853-2024-02624
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001188
• UDI-Public: 10705036001188
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B12SRT
• Device Lot Number: A9DD1X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1