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

Catalog Number 2B5LT

Device Problems Bent (1059); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p9432d.Investigation summary: the analysis results found that a 2b5lt device was returned with no damage in the external components.Upon testing, the obturator was inserted and removed with difficulties through the sleeve.The device was disassembled, in order to evaluate the condition of the seals and was confirmed that the seals were found damage and the lubricant was insufficient from the seals causing the removing issue.The most likely cause for the found condition is related to the manufacturing process.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during an unknown procedure, the trocar would insert pre-use all ok, but when the surgeon used it and went to remove the trocar, they were bent and difficult to remove.No patient consequence.

• Brand Name: OPT BLADELESS 5X100 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7343501
• MDR Text Key: 102626090
• Report Number: 3005075853-2018-08565
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036013706
• UDI-Public: 20705036013706
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 2B5LT
• Device Lot Number: P4T665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1