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 # p92r4r.Device analysis: the analysis results of the d5lt found that it was received with the reset button in disarmed position.In addition, the tyvek(p4rl6w) from another device was returned along with the instrument.The instrument was armed and when the device was functionally tested the bullet did not retract as expected.No conclusion could be reached as to what may have caused the reported incident.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
During surgery, the dialating trocar knife has not been came out, port site insertion couldn¿t be proceed with blunt tip of trocar, so surgeon used new trocar.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: 7907060
• Report Number: 3005075853-2018-13004
• Device Sequence Number: 1346395
• Product Code: GCJ
• UDI-Device Identifier: 10705036001591
• UDI-Public: 10705036001591
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/15/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 09/25/2018
• Patient Sequence Number: 1