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

Model Number ER320

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch#: unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.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.

Event Description

Er320 found on j&j stock trolly on level 1 at adhb.Someone had placed it on the trolly between friday night and monday morning.Still, in its sterile plastic packing, the device has written on it " faulty, redcap not covering tips." the red retaining cap has slipped off the end of the device exposing the device jaws.The jaw has then pierced the sterile plastic packaging.The person who wrote the message or left the device on the trolly is currently unknown.If other, describe: device not removed from original packaging.Patient status/ outcome / consequences: unknown.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study? unknown.(b)(6).Device property of: hospital.Device in possession of: (b)(4), product specialist.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.: true.

Manufacturer Narrative

(b)(4).Date sent: 2/13/2020.D4: batch # t9338h.Investigation summary: the analysis results found that er320 device was returned inside its package unopened.Upon visual inspection, it was observed that the tip cap was misassembled and the jaw exposure caused damage on the blister and tyvek.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9572512
• MDR Text Key: 213409353
• Report Number: 3005075853-2020-00195
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Device Lot Number: T40G0D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 01/27/2020
• Patient Sequence Number: 1