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

Catalog Number	2B5LT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robot assisted gastric sleeve, when inserting the 5mm obturator to gain access for the liver retractor in the sub xiphoid, a snap was felt and it was discovered that the obturator was cracked in half.This was just with the obturator not with the stability sleeve.No patient harm was reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/22/2023 d4: batch # x70217 additional information was requested and the following was obtained: "the obturator was used to gain access in the sub xiphhoid for the liver retractor.Upon inserting it the surgeon felt a little give so he pulled it out.When removed they noticed there was a little bend in it.The surgical tech then attempted to straighten the bend on the back table and this is where it broke.There were no fragments in the patient or left in the patient.1st follow up attempt to affiliate: did any pieces fall into the patient? no, item broke on the back table.If yes, were they retrieved? na will all pieces be returned with the device? all or most.If no, were they discarded? na" 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 returned with the obturator cannula damaged broken.The event reported was confirmed and it is related to improper use of the device.One possible cause for the damage found on the obturator, may be excessive external load placed on the device.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

• 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: 18192123
• Report Number: 3005075853-2023-08697
• Device Sequence Number: 7237996
• Product Code: GCJ
• UDI-Device Identifier: 10705036013709
• UDI-Public: 10705036013709
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2023

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 2B5LT
• Device Lot Number: X70217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown