MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Catalog Number ER320

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: unknown.Batch # r9551f.Device analysis: the analysis results found that an er320 device was returned inside its package unopened.The package was visually inspected and no damaged was observed.In addition, a methylene blue test was conducted and it was confirmed that the sterility was not compromised.No conclusion could be reached as to what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device lot r41922 number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch r9551f number, and no non-conformances were identified.

Event Description

It was reported that during pre-op to an unknown procedure, the tyvek has holes.Case completed with another device of the same product code.There were no patient consequences reported.There is no further information available about the event.

• Type of Device: CLIP, IMPLANTABLE
• 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: 8702397
• MDR Text Key: 148222257
• Report Number: 3005075853-2019-19763
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: ER320
• Device Lot Number: R41922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1