MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 45 LONG; STAPLE, IMPLANTABLE

Model Number	EC45AL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #t5d14n.Investigation summary: the analysis found that one ec45al device was returned with the closure trigger broken and with a reload loaded on the device.The reload was received fully fired.No functional test was performed due to the condition of the device.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.Due to the damage on the device, it is possible that that the device was clamped over an excess of tissue or a hard object, resulting in the damage to the closure trigger handle.As part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.Additional information was requested and the following was received: was it necessary to extend the incision? unknown.If yes how much was the incision extended? was a laparotomy required to manage the situation? unknown.Did any pieces of the device break off and fall into the patient? the locking lever broke off, but it was not fallen into the patient.If yes, were all pieces retrieved? did the stapler eventually open? no, the instrument has to be cut out with a second echelon device.How much small intestine tissue needed to be excised to perform the small intestine-small intestine anastomosis? unknown.What is the current patient status? unknown.Was there any patient consequence or change in the post-operative care of the patient as a result of the event (extended hospital stay, readmission, re-operation, etc.)? unknown.If yes, please explain.
Event or Problem Description
It was reported that during a gastric bypass, the locking lever broke off when triggered.After that, the device could no longer be opened.The instrument has to be cut out with a second echelon device.The surgery time was extended about 45 min, because another anastomosis (small intestine-small intestine) had to be done.No pieces fell into the patient.There were no patient consequences reported.

• Brand Name: ECHELON FLEX 45 LONG
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 9738716
• Report Number: 3005075853-2020-01158
• Device Sequence Number: 16329400
• Product Code: GDW
• UDI-Device Identifier: 10705036001683
• UDI-Public: 10705036001683
• Combination Product (Y/N): N
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2020

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: 05/28/2022
• Device Model Number: EC45AL
• Device Catalogue Number: EC45AL
• Device Lot Number: T93U79
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/21/2020
• Patient Sequence Number: 1