MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CURVED CIRCULAR STAPLER 29 MM; STAPLE, IMPLANTABLE

Catalog Number	CCS29
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.The lot history records were reviewed and the manufacturing criteria were met prior to the release of the lot.
Event or Problem Description
It was reported that during the endoscopic low rectal resection, after fired, found only with good cut line, but the staples malformed.Suture was used to sew the wound.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Batch # m54h3u.Device evaluation: the analysis results found that the ccs29 device arrived and with no apparent damage.The breakaway washer was present and uncut and the device was fully loaded with staples, indicating that the device had not being fired.The device was tested for functionality with the returned washer and it fired and 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 event described could not be confirmed as the device performed without any difficulties noted.The batch history record was reviewed and identified a defect/issue but was not related to the reported incident were found.In addition, no protocols or ncr related to the complaint, were found during the manufacturing process.

• Brand Name: CURVED CIRCULAR STAPLER 29 MM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7189237
• Report Number: 3005075853-2018-07338
• Device Sequence Number: 1174505
• Product Code: GDW
• UDI-Device Identifier: 20705036014062
• UDI-Public: 20705036014062
• 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,Followup
• Report Date (Section B): 12/25/2017

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: 06/14/2020
• Device Catalogue Number: CCS29
• Device Lot Number: M92133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 12/25/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1