MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number EL5ML

Device Problems Break (1069); Out-Of-Box Failure (2311); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.

Event Description

It was reported that before an unknown procedure, it was found that tyvek was damaged and there was a hole on the tyvek before the package was opened.The device was not used for the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).The el5ml package was visually inspected and it was confirmed that there was a hole in the tyvek lid.The hole was from the outside and appeared to be a snag from a pointed object that ripped and pulled the tyvek.There was tyvek material bunched and rippled around the rip showing a directional snag.The hole is not aligned with any part of the instrument or with the retainer.The damage was dye tested per tm5016 and the damage was verified to be a hole penetrating the tyvek.The investigation showed that the damage was likely caused by handling external to the ees packaging facility.The package contains a retainer placed over the instrument in the blister for package stabilization.Tyvek is handled by associate wearing gloves and processing one lid at a time to place upon the blister for sealing.The seal bar is directly vertical to the package so there is no way it could damage and snag the tyvek at an angle.Packages are 100% visually inspected immediately after sealing and the tyvek is never placed against any surface.Packages are placed into sales unit cartons immediately after visual inspection.There are no sharp corners, edges, or objects in the package handling areas.It is suspected that the damage occurred external to ees packaging facility.Complaint event is confirmed.Lot history records for m4hj0d, product code el5ml, were reviewed and no protocols, defects, non-conformances or quarantine noted.The product met all in-process and finished goods specifications upon release of the product.

• Brand Name: LIGAMAX CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5092276
• MDR Text Key: 26605620
• Report Number: 3005075853-2015-05998
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1