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

Catalog Number 2B5LT

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p94l10.Device analysis: the analysis results found that the 2b5lt device was returned with the obturator cannula damaged bent and inserted through the sleeve.In addition, the tyvek (p4t43r) from another device was returned along with the instrument.Upon testing, the obturator was 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 reported complaint was confirmed.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

Easy insertion of the sheath but to remove it got stuck inside, found out that it is indented in the middle part (device not used in the patient).Procedure: unknown.

• 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: 7590537
• MDR Text Key: 111156423
• Report Number: 3005075853-2018-10526
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036013706
• UDI-Public: 20705036013706
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 2B5LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1