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

Model Number	TB12LT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an endoscopic stomach surgery, after insert into the trocar, noted one device was broken ,and another device had cracks.Another two device were used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4) date sent: 6/14/2023 d4: batch # x95w6p additional information was requested and the following was obtained: the procedure should be endoscopic stomach.What portion of the trocar are you referring to? sleeve.Were the obturator handle locking buttons broken? unknown.Was the stopcock valve damaged? no.Was the outer seal damaged or the outer seal release lever? no.Did the trocar sleeve break off in patient? if so, were all parts retrieved from patient? yes, all were retrieved.Please confirm which portion of the trocar was broken.Top of sleeve.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 tb12lt device was received with the tip of the sleeve broken.In addition, the packaging opened was returned along with the instrument.Upon evaluation of the device, it was found the sleeve cap component disassembled and was observed to be not properly welded.No conclusion could be reached regarding what may have caused the reported incident.One possible cause for the damage found may be due to excessive force being applied to the device.Please refer to the instructions for use for additional information regarding proper device usage.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

• Brand Name: BASX BLADELESS TROCAR 12MM
• Common Device Name: LAPAROSCOPE, GENERAL & 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: 17130091
• Report Number: 3005075853-2023-04136
• Device Sequence Number: 7322998
• Product Code: GCJ
• UDI-Device Identifier: 10705036003007
• UDI-Public: 10705036003007
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

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 Model Number: TB12LT
• Device Catalogue Number: TB12LT
• Device Lot Number: 111C36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown