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

Catalog Number MCM20

Device Problems Difficult to Open or Close (2921); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unknown.Additional information was requested and the following was obtained: what is the correct product code for the device of issue as the attached complaint forms say the device of issue is an el5ml but the lot number is for an mcm20 (lot p4ru7g)? was user ever able to get the jaws of the device open during the procedure? no further information is available for this case.Per photographic evaluation: upon visual inspection of the picture, 1 clip can be fully observed, the clip appear to be malformed.The photo do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during an unknown procedure, the clip applier dispensed one clip which was deformed.Jaws compressed together and wouldn't open.A new clip applier used.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: 7245507
• MDR Text Key: 99763008
• Report Number: 3005075853-2018-07804
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20705036002472
• UDI-Public: 20705036002472
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2018

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: 06/30/2022
• Device Catalogue Number: MCM20
• Device Lot Number: P4RU7G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/06/2018
• Date Device Manufactured: 08/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1