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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 Crack (1135); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/03/2023
Event Type  malfunction  
Event Description
It was reported that during an unknown procedure, the tip was damaged.
 
Manufacturer Narrative
(b)(4) date sent: 11/30/2023 d4: batch # unk attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "were there any patient consequences? if yes, please describe." 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.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.
 
Manufacturer Narrative
(b)(4) date sent: 1/11/2024 d4: batch # x94z5t 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 the b12srt device was received with the tip of the sleeve damaged melted.In addition, the packaging opened was returned along with the instrument.The event reported was confirmed and it is related to improper use of the device.In order to prevent this kind of damage please avoid the contact with laser, electrosurgical or ultrasonic devices.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 batch and lot number, and no non-conformances were identified.
 
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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
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
Manufacturer Contact
kate karberg
475 calle c
guaynabo 
3035526892
MDR Report Key18240207
MDR Text Key329433599
Report Number3005075853-2023-08911
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10705036001188
UDI-Public10705036001188
Combination Product (y/n)N
Reporter Country CodeKS
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,Followup
Report Date 01/11/2024
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
Device Lot Number267C09
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/01/2023
Initial Date FDA Received11/30/2023
Supplement Dates Manufacturer Received12/14/2023
Supplement Dates FDA Received01/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/12/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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