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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLUNT TIP TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Model Number H12LP
Device Problems Crack (1135); Melted (1385); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2020
Event Type  Malfunction  
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 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.

 
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Brand NameENDOPATH XCEL BLUNT TIP TROCAR
Type of DeviceLAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
00969
Manufacturer Contact
kara ditty-bovard
475 calle c
guaynabo 00969
  00969
6107428552
MDR Report Key9910975
MDR Text Key200047353
Report Number3005075853-2020-01910
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
PMA/PMN NumberK032676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/01/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH12LP
Device Catalogue NumberH12LP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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