MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 33MM, CURVED; STAPLE, IMPLANTABLE

Model Number	ECS33A
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/24/2020 date of event: only event year is known: 2020.Batch # unk.As the device was not returned, an analysis investigation could not be performed.  a conclusion could not be reached as to what may have caused or contributed to the event.  the lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during an unknown procedure, the device wouldn't fire.No other information is available.There were no patient consequences were reported.

• Brand Name: ILS 33MM, CURVED
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 10323301
• Report Number: 3005075853-2020-03793
• Device Sequence Number: 14416467
• Product Code: GDW
• UDI-Device Identifier: 10705036012412
• UDI-Public: 10705036012412
• Combination Product (Y/N): N
• PMA/510(K) Number: K940967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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 Model Number: ECS33A
• Device Catalogue Number: ECS33A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/24/2020
• Patient Sequence Number: 1