MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LAPRA-TY* ABSORBABLE CLIP APPLIER

Catalog Number KA200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Abdominal Distention (2601)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an unknown procedure, the lapra-ty would be grasp the clips.Tried a few times with no success.Someone after the case tried and it worked.They sent the device to sterile services which also noticed the device wouldn¿t grasp.It is unknown how the procedure was completed.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Batch # 08020.The analysis results found that the mic4030 device was received with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained and deployed 6 clips as intended over suture.The instrument was fully functional and conforming to our manufacturing requirements.No conclusion could be reached as to what may have caused the reported incident.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.

• 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: 6449206
• MDR Text Key: 71582024
• Report Number: 3005075853-2017-01741
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KA200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1