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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 B12LT
Device Problems Valve(s) (527); Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Batch # unk. Attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed. Additional information was requested, and the following was obtained: can you please clarify the event description provided of "some valves had been missing before use. "? was there a black rubber seal missing from the trocar? yes.

 
Event Description

It was reported that during an unknown procedure, it was found that some valves had been missing before use. There was no possibility that the missing valves were left inside the patient. Another device was used to complete the case. There were no adverse consequences to the patient.

 
Manufacturer Narrative

(b)(4). Batch # unknown. Device analysis: the analysis results found that only the universal seal from the b12lt device was returned with the seal damaged and torn; the seal torn was returned inside a bag. In addition, the seal was observed to have a mark which suggests that a pointy instrument was inserted through the trocar with excessive force. Per instructions for use: "use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum. Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal. " we did not receive a batch or lot number for the product involved in this complaint. Therefore, we were unable to check manufacturing records for any related non-conformances.

 
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Brand NameENDOPATH XCEL BLADELESS TROCAR
Type of DeviceLAPAROSCOPE, GENERAL AND PLASTIC SURGERY
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
Manufacturer Contact
milton garrett
475 calle c
guaynabo 00969
5133378865
MDR Report Key8499803
MDR Text Key141753999
Report Number3005075853-2019-17944
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 FOREIGN
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/10/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB12LT
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/01/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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