MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. FLEX 60 ARTICULATING; STAPLE, IMPLANTABLE

Catalog Number EC60A

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2018

Event Type  malfunction  

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 device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested, and the following was obtained: can you please provide more event details? did the device lock-out (no staples deployed and no cut line started)? no information.Or, did the device partially fire (start to deploy staples and cut but could not be completed)? no information.Did the device deliver any staples? no information.Was the device locked on tissue with the jaws closed? no information.Did the jaws eventually open? no information.No further information will be provided.

Event Description

It was reported that during a laparoscopic sigmoidectomy, the knife did not move forward at the first firing on the colon.The closing lever had a difficulty in grasping.The knife reverse switch did not function.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # r58y3x.The analysis found that one ec60a device was returned with no apparent damage and with an ecr60b partially fired 1/16 cartridge loaded on the device.The returned device and cartridge reload were tested for functionality in the articulated position by resetting and reloading it into the device.The device achieved its complete stroke firing sequence without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper b-form shape.It is possible that while loading the reload, the cartridge was pushed farther back than the cartridge alignment stop windows resulting in the knife pushing the one piece sled forward and locking the cartridge.The device opened and closed without any difficulties noted.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: FLEX 60 ARTICULATING
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8043436
• MDR Text Key: 126397756
• Report Number: 3005075853-2018-14205
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001706
• UDI-Public: 10705036001706
• Combination Product (y/n): N
• PMA/PMN Number: K081146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Catalogue Number: EC60A
• Device Lot Number: R93M0N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 11/07/2018
• Supplement Dates FDA Received: 12/03/2018
• Patient Sequence Number: 1
• Treatment: RELOAD: ECR60B, LOT#:R40L6L