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	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a gastric procedure, when opening the kit, it was identified that the cannula packaging was torn, and it was necessary to change the material.No patient consequences.
Additional Manufacturer Narrative
(b)(4).Batch # unk.This is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photograph shows a damaged blister.Unfortunately the photo does not provide enough evidence to determine the root cause.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16246728
• Report Number: 3005075853-2023-00541
• Device Sequence Number: 6406729
• Product Code: GCJ
• UDI-Device Identifier: 10705036001331
• UDI-Public: 10705036001331
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 01/26/2023

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: 931A87
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female