MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CURVED CIRCULAR STAPLER 25 MM; STAPLE, IMPLANTABLE

Catalog Number	CCS25
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation: the analysis results found that the (b)(4) device arrived with no apparent damage.The breakaway washer was present, cut and the device was fully fired.In addition another washer was received, it was cut.Further analysis of the device showed that the trocar was damaged no allowing the anvil to properly assemble on the device.Once the anvil was attached to the device it was difficult to remove.No functional test was performed due the condition of trocar.No conclusion could be reached as to how the trocar became damaged.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Photographic analysis: picture provided shows a device over a blister, the safety is not engaged, the anvil and the washer can be seen aside of the device.Based on the photo alone the event describe is confirmed.
Event or Problem Description
It was reported that during the endoscopic gastric surgery, went to insert anvil into patient, found the breakaway washer falling off.Another like product was used to complete the procedure.There were no patient consequences reported.

• Brand Name: CURVED CIRCULAR STAPLER 25 MM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7094925
• Report Number: 3005075853-2017-06521
• Device Sequence Number: 1495576
• Product Code: GDW
• UDI-Device Identifier: 20705036014055
• UDI-Public: 20705036014055
• Combination Product (Y/N): N
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

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 Expiration Date: 03/05/2022
• Device Catalogue Number: CCS25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1