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

Catalog Number MCL20

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only event day (5) and even year (2018) known.Batch # unknown.Device analysis: there was no sample received for analysis.Only a picture of the sample was received for analysis.Upon visual inspection of the picture, there appears to be two holes in the tyvek, there appears to be a wrinkly section in each hole that suggests the package was dragged against a pointy surface, thus, suggesting handling issues.However, no conclusion could be reached as to the origin of the reported incident as the device was not returned for analysis.The photos do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.Should the sample become available please contact the clinical inquiry service or your sales representative.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.

Event Description

It was reported that a hole was discovered in the tyvek packaging.It was not during a procedure.There were no patient consequences reported.

• 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: 7448062
• MDR Text Key: 106170770
• Report Number: 3005075853-2018-09255
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20705036002465
• UDI-Public: 20705036002465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: MCL20
• Device Lot Number: P4RX17
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/20/2018
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1