MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 11MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	D11LT
Medical Device Problem Codes	Gas/Air Leak (2946); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Additional information received: does the patient have a health condition that the surgeon evaluates as aggravating the event?: no.
Event or Problem Description
It was reported that during a oophorectomy, the product showed air leakage in the rubber (rubber running inside the trocar).
Additional Manufacturer Narrative
(b)(4), date sent: 12/8/2023.D4: batch # v9628f.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the d11lt device was returned with no damage in the external components.A leak test was performed and the device was noted to leak without the test probe inserted through the device.As each device is visually inspected and functionally tested during the manufacturing process, no conclusion could be reached as to what might have caused the reported event.No conclusion could be reached as to what might have caused the reported event.The reported complaint was confirmed.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.

• Brand Name: XCEL DILATING TIP TROCAR 11MM
• 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: orla o'mahony ; 475 calle c; guaynabo
• MDR Report Key: 14565010
• Report Number: 3005075853-2022-03516
• Device Sequence Number: 4943054
• Product Code: GCJ
• UDI-Device Identifier: 10705036001560
• UDI-Public: 10705036001560
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: D11LT
• Device Catalogue Number: D11LT
• Device Lot Number: 544A85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2022
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female