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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 Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Date sent: 11/22/2023.D4: batch # unk.Additional information was requested and the following was obtained: "there was no change in procedure (e.G.Additional port hole, additional wound) to remove the plastic piece.The patient is stable.The plastic piece will be returning with the device." investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that only the sleeve from the b12lt device was received broken.The of plastic from the sleeve was returned inside a plastic bag.In addition, the tyvek was returned along with the instrument.No conclusion could be reached regarding what may have caused the reported incident.One possible cause for the damage found may be due to excessive force being applied to the device.Please refer to the instructions for use for additional information regarding proper device usage.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
 
Event Description
It was reported that during a thoracoscopic esophagus procedure, plastic piece was found during the chest operation.It was found that the device was broken.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 Name
ENDOPATH XCEL BLADELESS TROCAR
Type of Device
LAPAROSCOPE, 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
kate karberg
475 calle c
guaynabo 
*  
3035526892
MDR Report Key18191645
MDR Text Key328800393
Report Number3005075853-2023-08682
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10705036001164
UDI-Public10705036001164
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,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 11/22/2023
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 NumberB12LT
Device Lot Number236C58
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2023
Initial Date Manufacturer Received 10/25/2023
Initial Date FDA Received11/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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