MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BASX BLADELESS SLEEVE 12MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	CTB12LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t92c4z.Additional information was requested, and the following was obtained: is there a picture or video of the foreign body that retrieved from the patient? i do not have any picture or video, but i sent both the trocar and the reducer cup to be analyzed.Clarification is needed, was the foreign body the dark gray inner seal? yes.Is it believed the ¿cup¿ fell into the patient during the 1st surgery (initial) or during the re-op (2nd procedure)? it is believed that happened during the 1st surgery.During the 2nd procedure was the ¿cup¿ retrieved? yes.Was there any mesh, raytec, or surgical sponges inserted through the trocar during the procedure (initial procedure)? no.What was the specific reason for the re-operation? there was a bleeding on the staple line, identified after the surgery was performed.Is it the hospitals normal routine to reprocess this specific type of trocar? no.Was this trocar re-processed? no.What instruments were passed through the trocar in the initial procedure? normally they passed the laparoscopic lens, our endocutters, instruments like graspers/scissors and also they use the sodium chloride solution bag from baxter to get the part of the stomach they take out of the patient´s body, they use that bag as if that was our pouch.Can the surgeon confirm that the foreign body is not the reason for the re-operation? yes.What product was used on the staple line that was bleeding which lead to the re-operation (please provide the product code)? the surgeon used : echelon powered (psee60a), green reloads (gst60g), blue reloads (gst60b).Device analysis: the analysis results found that the ctb12lt device was returned with the duckbill damaged and out of position.The duckbill was observed to have a mark which suggest that a snagging of an instrument during insertion with excessive force causing the duckbill out of position.Per instructions for use: "use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal." a manufacturing record evaluation was performed for the finished device batch t92c4z number, and no non-conformances were identified.
Event or Problem Description
It was reported that after a laparoscopic gastric sleeve, where a basx trocar was used.The trocar reducer was inside the patient.Intervention was required due to the situation.The surgeon identified the staple line was bleeding so he needed to operate that patient again.The incision was not made bigger.The intra-op procedure was not changed because the surgeon did not realize the reducer cup fell into the patient during the procedure.No xrays were taken to assist in locating the reducer cap.The surgeon realized that reducer cup was inside the patient once he was operating the patient again.The patient is safe and at home.
Additional Manufacturer Narrative
(b)(4).Additional information requested and received: can you confirm if the sodium chloride solution was passed through the trocar? routinely the surgeon rolls the sodium chloride package so it is able to go through the trocar until it is inside the patient, where he uses it as a pouch to gather the piece of stomach he takes out of the patient.

• Brand Name: BASX BLADELESS SLEEVE 12MM
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8659892
• Report Number: 3005075853-2019-19438
• Device Sequence Number: 13974853
• Product Code: GCJ
• UDI-Device Identifier: 10705036001515
• UDI-Public: 10705036001515
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K062209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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: 01/31/2024
• Device Catalogue Number: CTB12LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 06/17/2019
• Patient Sequence Number: 1