MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*XCEL DIL TIP TROC PAK; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	K12LT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: v95t1k.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the k12lt device was returned with obturator inserted thru the sleeve and the sleeve assembly components separated and the stopcock was returned inside a plastic bag.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon¿s quality system.Additional information was requested, and the following was obtained: please clarify how the trocar ¿was broken during skin penetration.It didn't work properly¿.Was the trocar having issues to insert? or was the sleeve broken during the skin penetration? or or was the obturator broken during the skin penetration? if other, please specify.Answer: using sterile technique, they have removed the instrument from the package.The trocar obturator and sleeve were packaged unassembled.To assembled, they removed the protective tip covering from the obturator and trocar sleeve and discard.They assembled the trocar by inserting the obturator into the trocar sleeve until they lock securely together.During penetration of the skin elements of the sleeve have been disassembled.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a bariatric gastric sleeve resection the trocar k12lt was broken during skin penetration.It didn't work properly and surgeon replaced it with k11lt.There was a 15 minute delay to surgery.There were no patient consequences.

• 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: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14459122
• Report Number: 3005075853-2022-03304
• Device Sequence Number: 14601670
• Product Code: GCJ
• UDI-Device Identifier: 10705036002284
• UDI-Public: 10705036002284
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

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: 08/31/2026
• Device Model Number: K12LT
• Device Catalogue Number: K12LT
• Device Lot Number: 471A06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown