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

Catalog Number	B5LT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/28/2024.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: "it was stated that the account uses stryker reprocessed devices.Was the device used in this event reprocessed?" additional information was requested and the following was obtained: "¿what was the procedure? lap chole ¿what is the surgeons experience with device? several years of experience.¿what was the anatomical position of this specific port? unknown.¿is it possible the trocar point made contact with the ribs upon insertion? unknown.¿were there any other intra op complications? n/a ¿were any deficiencies noticed before or during device use? no ¿was there excessive torquing of the instrument? no ¿what instruments were passed through the trocar? grasper ¿does the account use reprocessed trocars or does the account reprocess the trocars in house at the account? yes- stryker reprocessed ¿what is the current patient status? recovered ¿will device be returning for analysis? if it has been shipped, please provide tracking information.No".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.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/16/2024.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.Additional information was requested and the following was obtained: "yes, the device used in this event was discovered to be a stryker reprocessed trocar.".

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Common Device Name: 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 Key: 19127283
• Report Number: 3005075853-2024-03009
• Device Sequence Number: 8283759
• Product Code: GCJ
• UDI-Device Identifier: 10705036001225
• UDI-Public: 10705036001225
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: B5LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 06/18/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 05/28/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown