MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number B5LT

Device Problem Crack (1135)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 4/17/2024.D4: batch #: unk.Additional information was requested and the following was obtained: "the patient is recovering after re-operation to remove the tip of the trocar on (b)(6) 2024.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) yes.The tip of the trocar was detected via ultrasound in the subcutaneous tissue of the patient.This required re-operation on (b)(6) 2024." 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: "what was the procedure? what is the surgeons experience with device? what was the anatomical position of this specific port? is it possible the trocar point made contact with the ribs upon insertion? were there any other intra op complications? were any deficiencies noticed before or during device use? was there excessive torquing of the instrument? what instruments were passed through the trocar? does the account use reprocessed trocars or does the account reprocess the trocars in house at the account? what is the current patient status? will device be returning for analysis? if it has been shipped, please provide tracking information." an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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 unknown procedure, the tip of the trocar broke off inside the patient or within the packaging.Not able to retrieve the tip inside the patient but will if discovered later on or if patient experiences post-op issues.

• 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 Key: 19127283
• MDR Text Key: 340409125
• Report Number: 3005075853-2024-03009
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001225
• UDI-Public: 10705036001225
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B5LT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention