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

Model Number ER320

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.Date of event is 2021.Event day and event month were not reported.Additional information received: three photos were received for review.Review is in progress and has not yet been completed.Upon completion of photo review, a supplemental medwatch will be sent.Also rep reported the following: "the order was for a sample (not a demo)! i don´t know where this is packed but it has a j&j label on the side." product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

Event Description

It was reported that customer received sample order and the packaging was not what it should be.In a normal order, it has 3 eaches in one box, the items come in separate packaging with cardboard around each item, and have a big outer cardboard for all three.This sample was for one each only.This was delivered in a simple thin box with a "window" like a cake box.

Manufacturer Narrative

(b)(4).Date sent: 8/3/2021.H2: additional information received: this is review of three photos submitted for evaluation.During the visual analysis, the following was observed: the first photo shows a white box on a table.The second and third photos show a white box with a window and inside appears to be a package that belongs to one ligaclip device.The photos provided were compared against a johnson & johnson tyvek wrapper and the artwork complies with johnson & johnson standards.Based on the photos, the event described was confirmed, however no conclusion or root cause could be determined regarding how this reported event occurred.Hands on device analysis may have provided the additional evidence necessary to confirm the root cause of the reported event, however, because the instrument was not returned, our evaluation was limited.As part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11925887
• MDR Text Key: 254043686
• Report Number: 3005075853-2021-03060
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Device Lot Number: U40R2E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2021
• Patient Sequence Number: 1