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

Catalog Number	D5LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2018.Batch # p92p56.Device analysis: the analysis results of the d5lt found that it was received with the reset button in disarmed position.In addition, the tyvek was returned along with the instrument.In order to evaluate the reported incident, the instrument was functionally tested; the bullet did not retracted permitting the exposure of the blade during the advancement through the skin test media causing the insertion issues.No conclusion could be reached as to what may have caused the reported incident.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
When surgeon used d5lt, the knife of trocar wasn't came out, so it was hard to import trocar to abdomen of pateint.So surgeon decided to use new one.There were no patient consequences.

• 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
• MDR Report Key: 7819951
• Report Number: 3005075853-2018-12382
• Device Sequence Number: 1287038
• Product Code: GCJ
• UDI-Device Identifier: 20705036001598
• UDI-Public: 20705036001598
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• 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
• Report Date (Section B): 04/12/2018

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: 05/31/2022
• Device Catalogue Number: D5LT
• Device Lot Number: P4RN6P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 08/27/2018
• Patient Sequence Number: 1