MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC LIGACLIP; CLIP, IMPLANTABLE

Model Number ER420

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/23/2022

Event Type  malfunction  

Event Description

Clip applier opened by scrub tech and she saw copious amounts of white film on end of clip applier that flaked off when she engaged the clip.Item passed off field and supervisor called before patient was in the room.

• Brand Name: LIGACLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 14999477
• MDR Text Key: 295774747
• Report Number: 14999477
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Device Lot Number: X94H15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2022
• Date Report to Manufacturer: 07/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA