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

Catalog Number MCM20

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t9358e.Investigation summary: the analysis results found that the mcm20 device was received empty.In addition a plastic bag was received with an unformed clip.After the last clip is used, the instrument is designed to lock out, which prevents the handles from being squeezed; therefore a potential cause of the customer reported experience is the firing of all of the clips and the instrument "will not fire" (activation of the lock out mechanism).Due to the condition of the device, no functional testing could be performed to evaluate the incident reported.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.No conclusion could be reached as to what may have caused the reported incident as the device was returned empty.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device lot and batch number and no non-conformances were identified.

Event Description

It was reported that during an open unknown procedure, the target tissue was not clipped firmly as if the deployed clips would have come off the tissue.The device was used on the blood vessel.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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: 8996950
• MDR Text Key: 199101171
• Report Number: 3005075853-2019-21915
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002475
• UDI-Public: 10705036002475
• 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: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCM20
• Device Lot Number: T40F51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Date Manufacturer Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1