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

Catalog Number	CB12LT
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/3/2024.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: "is the current patient status known? 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.)".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 cholecystectomy procedure, the surgical procedure is carried out without any issues.Almost at the end of the surgery, the piece is removed from the cavity, removing the trocar with the clip and the bag with the piece through the transparent cannula, releases everything and re-inserts the shirt without the punch in the cavity.At the time of making a final review of the procedure, the doctor introduces a laparoscopy forceps and the duck beak seal falls into the abdominal cavity.Examination is done and the seal is removed from the cavity together with the 12 mm shirt, removing the product from the surgical field.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/18/2024.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D4: batch # unk.Additional information was requested and the following was obtained: "1.-without any complications, the trocar was changed, delaying the surgery a little but they continued without any eventuality 2.-no" investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the cb12lt device was received with the duckbill out of position and present.Due to the condition of the retuned device had no leak tested could be performed to evaluate the reported incident.However, it is known from the history of the device that the condition of the duckbill out of position may lead to insufflation issue.No conclusion could be reached as to what might have caused the duckbill out of position.A manufacturing record evaluation was performed for the finished device lot number 788c14, 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: 19667501
• Report Number: 3005075853-2024-04902
• Device Sequence Number: 7017283
• Product Code: GCJ
• UDI-Device Identifier: 10705036001331
• UDI-Public: 10705036001331
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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 Catalogue Number: CB12LT
• Device Lot Number: 788C14
• 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: 06/09/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown