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

Catalog Number EC45A

Device Problems Defective Component (2292); Firing Problem (4011)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Batch # t5az5f.Investigation summary: the analysis results showed that one ecr45b cartridge reload was received.The reload was received partially fired 1/3 and with damage on cartridge deck.No functional test was performed due the condition of the reload.The damage to the cartridge is consistent with the device being clamped over a hard object.To mitigate the potential for staples getting into the cartridge and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and cartridge jaw in sterile solution and then wipe the anvil and cartridge jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.The partially fired is consistent with an incomplete or interrupted cycle.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.Additional information requested and received: what is the surgeon¿s experience with device? experienced, so could disassembled the device.Was the device difficult to close? no.Were the forces to fire higher or lower than expected? unk.How many firing strokes were able to be completed? this firing is 1st one as the event description shows.What trouble-shooting steps were taken to open device? followed up ifu.What is meant by ¿disassembled¿? disassembled the device into component level.Was any damage to device noticed prior to disassembling? no, but only checked the appearance of the device.How was the device eventually opened? no, used another device to cut the tissue and removed the device with close jaw.What is the current patient status? stable.

Event Description

It was reported that during the laparoscopic right hemicolectomy surgery, could not fire farther after fired a little when severing the right colon tissue on the 1st firing.Could not return the blade, the knife reverse button did not work, disassembled the ec45a, but still could not removed the device, enlarged the incision,used one new gun to cut the tissue and removed the device.The gun was discarded, the reload could be returned.The surgery delayed about 2 hours.The patient is stable and in hospital now.

• Brand Name: ECHELON FLEX 45 STANDARD
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 9097407
• MDR Text Key: 161808871
• Report Number: 3005075853-2019-22231
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001676
• UDI-Public: 10705036001676
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EC45A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention