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

Catalog Number TLC75

Device Problem Material Rupture (1546)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

(b)(4).Date sent: 1/15/2016.Information was not provided by the initial contact.Information is unavailable.Batch # unk.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 lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.The following information was requested, but unavailable: could you please confirm if the device returned was used in initial operation? can you please confirm the procedure? what were the indications for surgery? were there staple formation issues noted in primary procedure? was the surgeon able to identify where on staple line there was an opening? were there any other stapling devices used in procedure? how was leak diagnosed? what is the current patient status? would the surgeon be willing to speak with engineering and medical? response: there is no additional information available.Additional information was obtained: was at home already when after 16 days he felt unwell and in hospital they found an insufficiency.During that second surgery the patient died.It was reported that the general condition of the patient was very bad ¿ so there is no clear connection between our instrument and the death of the patient as his condition was very bad when he came to the hospital for the second time.We have written confirmation from chief surgeon (e-mail) for the mentioned case that the reported event is not related to our device.Additional follow up is being done regarding this written statement.

Event Description

It was reported that after a duodenum stump procedure, the next day the staple line got open, sutured by hand.No further information is available.

Manufacturer Narrative

(b)(4).Additional information received: clarification to the statement from the chief surgeon: ¿translation of the written confirmation from the chief surgeon who is the medical expert stated that in his opinion neither our device nor the handling of the device caused the reported events.¿ in addition, the file was reviewed by the ees medical safety officer who supports the decision to revise the file to not reportable.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event, and has been revised to not reportable.

• Brand Name: PROXIMATE LINEAR CUTTER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5370845
• MDR Text Key: 36109496
• Report Number: 3005075853-2016-00361
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: TLC75
• Device Lot Number: M4HT9V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 80 YR