MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 12MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	D12LT
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 4/9/2024.D4: batch # unk.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.
Event or Problem Description
It was reported that during a laparoscopic myomectomy, when inducing the trocar in the umbilical site, blood spurting from right common ileoartery when viewing it using a camera port.Procedure was converted to open laparotomy to secure bleeding.On march 27, patient was facing bowel injury and had to undergo another laparotomy.Patient is still in hospital currently.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/5/2024.Additional information was requested and the following was obtained: 1.What is alleged deficiency against the ethicon device? ans: surgeon commented that usually the d12lt trocar blade will retract upon insertion of trocars into the patient body.However, this time it does not retracted.2.What is the surgeons experience with this device? ans: hcp is a very experience surgeon laparoscopic surgeon which has used d12lt ( this device ) more than 100 times and more.3.Were any blood products given? if so, how much? ans: no.4.Was there excessive pressure or torquing during insertion? ans: it is the same method and same method as previous case.Normal insertion of trocars required torquing when inserting into patient body.5.Were any adhesions or other intraoperative patient findings discovered? ans: the patient is skinny and thin patient.The space of abdominal might be small.Hcp comment that one of her hand holding the skin and the other holding the trocars, slippery of skin result in trocars enter the patient body.However, the hcp noted that the trocar's knife blade failed to retract, resulting in injury to the vessels.Surgeon comment that there is a cut on the main vessels common iliac vessels.The trocars should have mechanism to retract back the knife upon entering the abdominal.6.What is current patient status? ans: patient almost life threatening as she is required to close common artery vein.Patient have to be converted open and perform laparotomy.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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

• Brand Name: XCEL DILATING TIP TROCAR 12MM
• 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: 19069579
• Report Number: 3005075853-2024-02701
• Device Sequence Number: 4732544
• Product Code: GCJ
• UDI-Device Identifier: 10705036001577
• UDI-Public: 10705036001577
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: D12LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 09/05/2024
• 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