MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 5X100MM STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	2CB5LT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.Attempts are being made to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during a bariatric procedure, the trocar cannula broke in two pieces when inserting the liver retractor.Both pieces were easily retrieved and no complications to patient were reported.The procedure was successfully completed and there were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/20/2021.D4: batch # 234a16.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined the 2cb5lt device was received with the sleeve melted in the middle part of sleeve and with no obturator present.No functional test was performed due to condition of device.One possible cause for this type of damage may be interaction with an energized device used during the procedure.Caution should be taken to avoid contact between an energized device and the trocar during the surgical procedure.Please reference the instructions for use for more information.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number and no non-conformances were identified.

• Brand Name: OPT SLEEVE 5X100MM STABILITY
• 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
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12825095
• Report Number: 3005075853-2021-06982
• Device Sequence Number: 19976248
• Product Code: GCJ
• UDI-Device Identifier: 10705036013730
• UDI-Public: 10705036013730
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: 03/31/2026
• Device Model Number: 2CB5LT
• Device Catalogue Number: 2CB5LT
• Device Lot Number: 234A16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown