MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	2B5LT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 8/27/2024.D4: batch # y7016c.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 2b5lt device was received with the tip of the sleeve broken and the piece of plastic from the sleeve was returned inside a plastic bag.In addition, the tyvek was returned along with the instrument.No conclusion could be reached regarding what may have caused the reported incident.One possible cause for the damage found may be due to excessive force being applied to the device.Please refer to the instructions for use for additional information regarding proper device usage.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that during a robotic sleeve gastrectomy procedure, that while advancing the trocar from the peritoneum deeper in the abdomen when it snapped in half.All fragments were retrieved.Another like device was used to continue with the procedure.There were no adverse consequences for the patient.

• Brand Name: OPT BLADELESS 5X100 STABILITY
• 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: 20076315
• Report Number: 3005075853-2024-06320
• Device Sequence Number: 16910229
• Product Code: GCJ
• UDI-Device Identifier: 10705036013709
• UDI-Public: (01)10705036013709(17)290430(10)983C59
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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: 2B5LT
• Device Lot Number: 983C59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown