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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that a bug was found in the sterile trocar package.The procedure was completed with an alternate like device with no patient consequences reported.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Batch # r92635.Device analysis: the analysis results found that a d5lt device was returned inside its package unopened.The package was visually inspected and a foreign matter was observed to be inside.Inspection of the package consisted of tearing the package open and inspecting the foreign matter under magnification.Inspection under magnification revealed that the object was not an insect but a piece of black plastic.The plastic particle was measured at 8 mm.The most probable cause for the source of the plastic foreign matter is related to flash from the device which became dislodged after the affected device was packaged.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.

• 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: 7961490
• Report Number: 3005075853-2018-13581
• Device Sequence Number: 16492523
• Product Code: GCJ
• UDI-Device Identifier: 10705036001591
• UDI-Public: 10705036001591
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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: 12/31/2022
• Device Catalogue Number: D5LT
• Device Lot Number: R4033C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 11/09/2018
• Patient Sequence Number: 1