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

Catalog Number GST60G

Device Problems Sticking (1597); Failure to Form Staple (2579)

Patient Problem No Code Available (3191)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 5/18/2017.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 device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.Additional information received: after completing the firings, the staple line was over sewn with monocryl suture due to concerns of tissue sticking to cartridges.It was also mentioned that the patient had psoriasis and if there could be a possible link between an increase in tissue sticking with this skin issue.Additional information requested but unavailable: what other symptoms, other than tachycardia, defined the reoperation? during reoperation, was it confirmed that there was a gastric content leak or bleeding? if bleeding, was a transfusion required? will the reloads be returned for analysis? what is the current patient status?.

Event Description

It was reported that during a laparoscopic sleeve gastrectomy procedure, the surgeon used six gst60g reloads for the whole length of the sleeve from the pylorus to the fundus; this has been their usual practice even with our echelon ecr60g reloads and ple60a guns.When the six firings were done, the surgeon experienced tissue sticking on the reload for three firings.The tissue was stuck to the reload mainly at the medial to distal portion of the reload surface.While attempting to carefully remove the stuck tissue that is on the reload surface, a staple was seen pulled off the staple line in one of the three occasions.That particular portion was than over-sutured with a covidien v-loc suture.Monocryl was also used to secure the newly formed greater curve to omentum.Proper washing and reloading of staple reload have been adhered to and the product specialist was in the case.The surgeon also waited fifteen seconds to ensure sufficient pre-compression before each firing.The patient was reported to have tachycardia on the morning of (b)(6) (post-op day one).As of 10 am the patient was then wheeled into emergency ot, and an emergency reoperation was performed.During the reoperation, it was observed that the fifth firing around the fundus area had a leak.The staple line was then over-sutured.Currently, no complications are observed.

Manufacturer Narrative

(b)(4).Batch number: p55p41.Batch number: p5613h.Mfg 3/29/2017 exp 2/28/2022 investigation summary: the analysis results showed that gst60g cartridge reloads (a, e) were received.The reloads were received fully fired and with damage on cartridge deck.The found damage on the deck is consistent when the device is fired over an already existing staple line.When this happens, the knife plows the staples on cartridge deck and shaving may occurs.In order to verify the condition of the internal components of the reload it was disassembled and no anomalies were noted.No functional test could be performed due to the condition of the reload.The analysis results showed that gst60g cartridge reloads (b, c, d, f) were received.The reloads were received with no apparent damage and fully fired.No functional test could be performed due to the condition of the reload.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.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.Was buttressing material used? is it routine for surgeon to use v-loc suture in gi tract? were there any staple form issues noted in initial procedure or reoperation? what type of suture was used to close the leak during second procedure? what is the current patient status?.

• 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: 6576649
• MDR Text Key: 75472096
• Report Number: 3005075853-2017-02657
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K110385
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2022
• Device Catalogue Number: GST60G
• Device Lot Number: P4R87G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2017
• 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): Required Intervention