MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X75 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	2B5ST
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 8/23/2024 b3: unknown, assumed first day of month that complaint was reported d4: batch # c9dl1n.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: "was there physical damage to the trocar? please specify the part of trocar.Was the tip of the trocar obturator broken? if yes, was it separated from the device? if yes, did it fall into the patient was there an issue related to inserting the trocar? was there an issue with a seal? was there an issue with the trocar sleeve? was there an insufflation issue? please provide more product issue detail." investigation summary according to the information received the 2b5st device had not specified.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 2b5st device was returned with the obturator cannula damaged bent and inserted through the sleeve.The sleeve broken.In addition, the packaging opened was returned along with the instrument.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.One possible cause for the damage found on the sleeve 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 number, and no non-conformance's were identified.
Event or Problem Description
It was reported that during a gyn procedure, a 5mm trocar malfunctioned.The procedure was completed successfully with no adverse consequences for the patient.No surgical delay was reported.

• Brand Name: OPT BLADELESS 5X75 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: 20048080
• Report Number: 3005075853-2024-06232
• Device Sequence Number: 12752511
• Product Code: GCJ
• UDI-Device Identifier: 10705036013716
• UDI-Public: (01)10705036013716(17)290228(10)899C10
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2024

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: 2B5ST
• Device Lot Number: 899C10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown