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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 B5LT
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Date sent: 11/20/2023.D4: batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number 526c95, and no non-conformances were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported that during an esophageal surgery, after insert into the trocar, noted the device was broken.Removed the fragment from the body, then changed another device to continue the surgery, the same problem happened again.Another device was used to complete the surgery.There was no patient consequence reported.No additional information could be provided.
 
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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 Key18173796
MDR Text Key328567356
Report Number3005075853-2023-08593
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10705036001225
UDI-Public10705036001225
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K032676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/20/2023
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 NumberB5LT
Device Lot Number526C95
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/22/2023
Initial Date FDA Received11/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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