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	10/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # l5337r.Device evaluation: the analysis results showed that the cr40b reload was received with no apparent damaged and fully loaded with staples, with the washer uncut and with the knife recessed below the reload deck.The staples were noted to be protruding; no functional test was performed due to the condition of the reload.The condition of the returned reload is consistent with the device being partially activated.Do not fire the instrument unless the closure trigger is properly latched against the handle.The firing trigger must be pulled back completely against the closure trigger to properly fire the instrument.In addition if the firing sequence is not complete, you could deploy the staples without cutting the washer and forming the staples.Please reference instructions for use for additional information.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were there any patient consequences?.
Event or Problem Description
It was reported that during an unknown procedure, impossible for the surgeon to put a reload in the device (mechanism blocked).Another device was used.
Additional Manufacturer Narrative
(b)(4).Were there any patient consequences? no.

• 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: 8102288
• Report Number: 3005075853-2018-14406
• Device Sequence Number: 2364009
• Product Code: GDW
• UDI-Device Identifier: 10705036001423
• UDI-Public: 10705036001423
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040038
• 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): 08/17/2018

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: 07/29/2019
• Device Catalogue Number: CR40B
• Device Lot Number: L4F355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1