MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 5MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	D5LT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the tip of the trocar screws up, making it impossible to use.No patient consequences.
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation is pending.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "did any pieces fall into the patient? if yes, were they retrieved? will all pieces be returned with the device? if no, were they discarded?" attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4), date sent: 8/7/2023.D4: batch # x95r63.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 d5lt device was returned with no apparent damage.In addition, the tyvek was returned along with the instrument.The device was visually inspected and no damaged found on the sleeve.The device was fully functional according to the manufacturing requirements.The event described could not be confirmed as the device was returned without any damaged.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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.
Additional Manufacturer Narrative
(b)(4) date sent: 5/16/2023 d4: batch # unk a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information was requested and the following was obtained: "was the surgery postponed due to the reported event? no did the procedure complete successfully? not reported fragments were generated? no patient/ result/ consequences -not informed was any other medical intervention required (e.G.X-rays, additional procedures, prescriptions, otc, revision): -no 3rd additional information requested: did any parts fall inside the patient? no will all parts be returned with the device? yes.".

• Brand Name: XCEL DILATING TIP TROCAR 5MM
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16765154
• Report Number: 3005075853-2023-02709
• Device Sequence Number: 6182439
• Product Code: GCJ
• UDI-Device Identifier: 10705036001591
• UDI-Public: 10705036001591
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup,Followup
• Report Date (Section B): 08/07/2023

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: D5LT
• Device Catalogue Number: D5LT
• Device Lot Number: 106C06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 07/11/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/16/2023; 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown