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

Catalog Number 2B12LT

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.As a lot/batch was not provided, a device history could not be performed.

Event Description

Trocar couldn´t break through.Rubber seal not pierced.There were no consequences for the patient.

Manufacturer Narrative

(b)(4).Batch # r93m19.The analysis results found that the 2b12lt device was returned with no damage to the external components.In an attempt to replicate the reported incident, the device was tested for functionality.During testing, they attempted to introduce the obturator into the sleeve assembly, however it could not be introduced due to a closed duckbill.This condition is most likely related to the manufacturing process.The batch history record was reviewed and no defects, ncr¿s, or protocols related to the complaint were found during the manufacturing process.

Manufacturer Narrative

(b)(4).Batch # r93m19.The analysis results found that the 2b12lt device was returned with no damage to the external components.In an attempt to replicate the reported incident, the device was tested for functionality.During testing, they attempted to introduce the obturator into the sleeve assembly, however it could not be introduced due to a closed duckbill.This condition is most likely related to the manufacturing process.The batch history record was reviewed and no defects, ncr¿s, or protocols related to the complaint were found during the manufacturing process.

• 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
• MDR Report Key: 7983552
• MDR Text Key: 124558412
• Report Number: 3005075853-2018-13749
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036014218
• UDI-Public: 10705036014218
• Combination Product (y/n): N
• PMA/PMN Number: K122512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 2B12LT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 10/24/2018
• Supplement Dates FDA Received: 11/14/2018
• Patient Sequence Number: 1