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

Catalog Number MCM30

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only event year known: 2019.Batch # m9035v.Device analysis: the analysis results found that mcm30 device was returned inside its package unopened.Upon visual inspection, it was observed that the tyvek from the packaging was damaged; it was noted to have a hole in the tyvek, the hole was noted to be from the outside in.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.The reported complaint was confirmed.All (b)(4) product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.A manufacturing record evaluation was performed for the finished device lot number m4h26w, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number m9035v, and no non-conformances were identified.

Event Description

It was reported that the outside package is broke.This did not occur in sterile processing or field inspection.There were no patient consequences.

• 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: 8447861
• MDR Text Key: 139810634
• Report Number: 3005075853-2019-17499
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002482
• UDI-Public: 10705036002482
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: MCM30
• Device Lot Number: M4H26W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Date Manufacturer Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1