MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LAPRA-TY* APPLIER - 33CM; APPLIER, SURGICAL CLIP

Catalog Number	KA200
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2019.Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was the device difficult to open and close the jaws, sticking?.
Event or Problem Description
It was reported that the jaws of the instrument were not opening and closing.No patient involvement occurred.
Additional Manufacturer Narrative
(b)(4).Device analysis: the analysis results found that the ka200 device was returned with the trigger detached from the tube, as the pin handle pivot was noted to be missing.No functional test was performed due to the condition of the device.No conclusion could be reached as to what may have caused the found condition of the trigger.Please note that as stated in the ifu: "all surgical instruments are subject to a degree of wear and tear because of normal use.A regular and precise visual check of the instrument should be made before each use." the batch history records were reviewed and certified by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.  the certificate records are accessible through external manufacturing. .

• Common Device Name: APPLIER, SURGICAL CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8253431
• Report Number: 3005075853-2019-15995
• Device Sequence Number: 19508479
• Product Code: GDO
• UDI-Device Identifier: 10705036012641
• UDI-Public: 10705036012641
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: KA200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/05/2019
• Patient Sequence Number: 1