MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 12X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number 2B12LT

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown surgery, it was difficult to get instruments in and out of the trocar.Another device was used to complete the surgery.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Date sent: 12/08/2022.D4: batch # x95d88.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 2b12lt device was received with the duckbill closed.Not allowing the obturator to be inserted trough the sleeve.No conclusion could be reached regarding what may have caused the reported incident.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 x95d88 number, and no non-conformances were identified.

• Brand Name: OPT BLADELESS 12X100 STABILITY
• Type of Device: 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 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 15815547
• MDR Text Key: 307592052
• Report Number: 3005075853-2022-08028
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036014218
• UDI-Public: 10705036014218
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

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
• Device Operator: Health Professional
• Device Model Number: 2B12LT
• Device Catalogue Number: 2B12LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1