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

Catalog Number	D11LT
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/22/2025.Additional information was requested, and the following was obtained: was sterility compromised from this event? yes.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.) unknown.
Additional Manufacturer Narrative
(b)(4).Date sent 8/7/2025 corrected data d4: udi# the device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent 7/17/2025.D4 batch # unk d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.No lot or batch number was provided therefore a device history could not be done.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: was sterility compromised from this event? 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.).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 when opening the sterile packaging of the product, large amount of white dusty material (appearing to be coming out of the plastic seal of the packaging) sprayed out potentially causing contamination of sterile field and the theatre.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/11/2025 investigation summary the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the d11lt device was returned inside it's package unopened.Upon visual inspection of the packaging, a foreign matter was noted to be on it and it was confirmed to be white flakes from the tyvek.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As part of our quality process, the manufacturing records of this lot number was reviewed, and the manufacturing standards were met prior to the release of this lot.Although no conclusion could be reached on how these white flakes get loose from the tyvek.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device lot 412a82 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 ; 3035526892
• MDR Report Key: 22530313
• Report Number: 3005075853-2025-05631
• Device Sequence Number: 7904010
• Product Code: GCJ
• UDI-Device Identifier: 10705036001560
• UDI-Public: (01)10705036001560(17)260731(10)412A82
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup,Followup
• Report Date (Section B): 08/11/2025

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 Expiration Date: 07/31/2026
• Device Catalogue Number: D11LT
• Device Lot Number: 412A82
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 07/21/2025; 07/28/2025; 08/07/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 07/22/2025; 08/07/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown