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

Model Number	CB12LT
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4), date sent: 7/7/2023, d4: batch # unk.Additional information was requested and the following was obtained: "please confirm, per device, which portion of the device packaging was damaged.Was the tyvek perforated? did the perforation result in a loss of sterility? the tyvek of both devices were perforated, which resulted in a loss of sterility.2 photos were provided".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 before the surgery, it was noted the packing was damaged.Changed to a different device, the same problem happened again.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/28/2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Brand Name: 12MM XCEL STABILITY SLEEVE
• 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: 17279680
• Report Number: 3005075853-2023-04747
• Device Sequence Number: 12033490
• Product Code: GCJ
• UDI-Device Identifier: 10705036001331
• UDI-Public: 10705036001331
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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: CB12LT
• Device Catalogue Number: CB12LT
• Device Lot Number: 570A81
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown