MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE* LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number TLC10

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.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.When the device could not be opened during surgery, was the device stuck on tissue? if yes, how was it removed? was the device cut off of the tissue? were the device forks eventually able to be opened? if yes, did this occur after it had been cut off of the tissue?.

Event Description

It was reported that during an open gastrectomy, the anvil half could not be separated from the cartridge half during use.The device was used on the stomach.Another device was used to complete the case.There were no adverse consequences to the patient.

• 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: 8236685
• MDR Text Key: 132796839
• Report Number: 3005075853-2019-15678
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036003120
• UDI-Public: 10705036003120
• Combination Product (y/n): N
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: TLC10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1