MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. RELOAD- CURVED CUTTER STAPLER; STAPLE, IMPLANTABLE

Catalog Number	CR40B
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.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.
Event or Problem Description
It was reported that during an unknown procedure the device was fired and no staples deployed.Upon inspection it was noted that the reload did not have any staples.A second reload was used to complete the procedure with no patient consequences reported.
Additional Manufacturer Narrative
Product complaint (b)(4).Batch # r5a506.Device evaluation summary: the analysis results found that the cr40b reload was received with no apparent damage and fully fired.No functional test was performed.The event described could not be confirmed as the reload was received fully fired.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: RELOAD- CURVED CUTTER STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8244062
• Report Number: 3005075853-2019-15890
• Device Sequence Number: 2203283
• Product Code: GDW
• UDI-Device Identifier: 10705036001423
• UDI-Public: 10705036001423
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040038
• 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): 12/21/2018

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: 08/25/2023
• Device Catalogue Number: CR40B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1