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

Model Number	H12LP
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during an unknown procedure, the tip of the device melted and cracked during use.There was a possibility that the device touched a harmonic device.No pieces were left inside the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: ENDOPATH XCEL BLUNT TIP TROCAR
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 9910975
• Report Number: 3005075853-2020-01910
• Device Sequence Number: 11420319
• Product Code: GCJ
• UDI-Device Identifier: 10705036002017
• UDI-Public: 10705036002017
• 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): 03/10/2020

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: H12LP
• Device Catalogue Number: H12LP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1