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	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # n56j8h.Device evaluation: the analysis results found that the ccs25 device arrived with no apparent damage with the staples present and protruding with the breakaway washer uncut.It should be noted that an inadvertent movement of the firing trigger after disengaging the safety might cause the staples to fall out or protruding.It is important to ensure that the adjusting knob is set in the firing range before disengaging the safety.Therefore, it is imperative that disengaging the safety be the last step prior to firing.For more information please refer to the instructions for use.The device was tested for functionality with the returned washer; the device formed all the staples, as well as completely cut the test media and the breakaway washer without incident.The staple line was complete and the staples were noted to have the proper b-formed shape.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that during the radical resection of esophageal carcinoma, before put in the patient, found the staples protruding.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: 7075304
• Report Number: 3005075853-2017-06392
• Device Sequence Number: 19115470
• 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): 09/29/2017

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: 08/24/2021
• Device Catalogue Number: CCS25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1