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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY Back to Search Results
Catalog Number B12SRT
Device Problems Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 06/17/2015
Event Type  malfunction  
Event Description
It was reported by the sales rep that before an unknown procedure, the sleeve housing dislodged in the sealed package.The package was not opened.Another device was used to complete the case.There were no adverse consequences to the patient.No device will be returning.(b)(4).
 
Manufacturer Narrative
(b)(4).Information asked for but unknown or not provided during initial contact.Information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.
 
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Brand Name
ENDOPATH XCEL BLADELESS TROCAR
Type of Device
LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo PR 00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 0096 9
Manufacturer Contact
milton garrett
5133378865
MDR Report Key4874493
MDR Text Key6260066
Report Number3005075853-2015-03895
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K032676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/17/2015
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
Device Operator Health Professional
Device Catalogue NumberB12SRT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/18/2015
Initial Date FDA Received06/29/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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