GORE SEAMGUARD Bioabsorbable Staple Line ReinforceRecalls & reported problems across all models

We found 3 models of GORE SEAMGUARD Bioabsorbable Staple Line Reinforce by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Jan 31, 2024 and Feb 1, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Form Staple” (1 report).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 3, 2024Class IIOpen, Classified

   Devices were labeled with an expiration date of four years and ten days rather than the validated two years.

   Z-2513-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported GORE SEAMGUARD Bioabsorbable Staple Line Reinforce problems

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE SEAMGUARD Bioabsorbable Staple Line Reinforce CBSG25

  Mesh, surgical, polymeric
  1 recall0 reports
• GORE SEAMGUARD Bioabsorbable Staple Line Reinforce BSGEC60AAC

  Mesh, Surgical, Polymeric
  3 reports
• GORE SEAMGUARD Bioabsorbable Staple Line Reinforce BSGEC60AC

  Mesh, Surgical, Polymeric
  1 report

Recent GORE SEAMGUARD Bioabsorbable Staple Line Reinforce adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2024Fluid/Blood Leak; Failure to Form Staple; Fluid/Blood Leak; Failure to Form Staple

  AT NUMEROUS TIMES THROUGHOUT 2023, THE PATIENT CALLED AND EMAILED GORE INQUIRING AS TO WHETHER GORE SHIPPED THE ETHICON STAPLER WITH ITS SEAMGUARD DEVICE. THE PATIENT REPORTED SHE HAS STOMACH CANCER AND STAPLES WERE COMING UNDONE AS A RESULT OF HER PHYSICIAN USING A RECALLED ETHICON STAPLER. VARIOUS GORE EMPLOYEES ADVISED THE PATIENT NUMEROUS TIMES THROUGHOUT 2023 THAT GORE DID NOT SELL OR SHIP THE ETHICON STAPLER. ON (B)(6), 2024 THE PATIENT FILED A LAWSUIT AGAINST GORE ALLEGING THE ECHELON FLEX ENDOPATH STAPLER RELOAD (BLACK, 60 MM X 4.4 MM, MODEL NO. ECR60T) AND THE GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT, PRODUCT 12BSGEC60 WERE DEFECTIVE PRODUCTS USED IN THE GASTRIC SLEEVE SURGERY PERFORMED ON (B)(6), 2016. REPORTEDLY, THE PATIENT ALLEGES THESE PRODUCTS CAUSED THE INCOMPLETE STAPLE LINE FORMATION RESULTING IN GASTRIC LEAK COMPLICATIONS. THE PATIENT REPORTED SHE HAS UNDERGONE CONTINUOUS TREATMENT FOR HER INJURIES CAUSED BY THE DEFECTIVE PRODUCTS AND RESULTING GASTRIC LEAK, INCLUDING, BUT NOT LIMITED TO, REMOVAL OF HER SPLEEN, REMOVED OF HER LEFT LOWER LUNG LOBE, AN ESOPHAGOSCOPY, GASTROSCOPY, DUODENOSCOPY FOR A PLEURAL FISTULA, REPAIR OF S DIAPHRAGMATIC HERNIA,

  Patient problems: No Clinical Signs, Symptoms or Conditions; Organ Dehiscence

  MAUDE report 18620629 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, DR. EICHLER HAS EXPERIENCED THREE PROCEDURES RECENTLY WHERE THERE WAS INFECTION AND ABSCESS AT THE STAPLE LINE. THIS IS A COMPLICATION HE DOESN¿T TYPICALLY SEE WITH SUCH FREQUENCY. THIS HAS LED HIM TO INVESTIGATE POTENTIAL SOURCES OF CONTAMINATION, AND/OR RULE OUT CONTRIBUTING FACTORS. THE PROCEDURES WERE ALL DUODENAL SWITCHES AND GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT WAS USED ON THE DUODENAL TRANSECTION. ADDITIONAL PRODUCTS USED IN THE PROCEDURE INCLUDE AN ETHICON STAPLER, AND BAXTER PERI-STRIPS STAPLE LINE REINFORCEMENT ON THE GASTRIC POUCH. IT WAS REPORTED THERE WAS A RE-OPERATION AND NO PRE-EXISTING INFECTION IN THE LOCATION OF THE DEVICE OR SURROUNDING ADJACENT TISSUES. REPORTEDLY, THE COLOR CARTRIDGE BEING USED WAS WHITE AND THE INFECTION DID OCCUR AT THE ANASTOMOSIS. IT WAS REPORTED THE INFECTION WAS TREATED WITH REOPERATION (WASHOUT).

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 18620601 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, DR. (B)(6) HAS EXPERIENCED THREE PROCEDURES RECENTLY WHERE THERE WAS INFECTION AND ABSCESS AT THE STAPLE LINE. THIS IS A COMPLICATION HE DOESN'T TYPICALLY SEE WITH SUCH FREQUENCY. THIS HAS LED HIM TO INVESTIGATE POTENTIAL SOURCES OF CONTAMINATION, AND/OR RULE OUT CONTRIBUTING FACTORS. THE PROCEDURES WERE ALL DUODENAL SWITCHES AND GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT WAS USED ON THE DUODENAL TRANSECTION. ADDITIONAL PRODUCTS USED IN THE PROCEDURE INCLUDE AN ETHICON STAPLER, AND BAXTER PERI-STRIPS STAPLE LINE REINFORCEMENT ON THE GASTRIC POUCH. IT WAS REPORTED THERE WAS A RE-OPERATION AND NO PRE-EXISTING INFECTION IN THE LOCATION OF THE DEVICE OR SURROUNDING ADJACENT TISSUES. REPORTEDLY, THE COLOR CARTRIDGE BEING USED WAS WHITE AND THE INFECTION DID OCCUR AT THE ANASTOMOSIS. IT WAS REPORTED THE INFECTION WAS TREATED WITH A REOPERATION AND ANTIBIOTICS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 18619012 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, DR. (B)(6) HAS EXPERIENCED THREE PROCEDURES RECENTLY WHERE THERE WAS INFECTION AND ABSCESS AT THE STAPLE LINE. THIS IS A COMPLICATION HE DOESN¿T TYPICALLY SEE WITH SUCH FREQUENCY. THIS HAS LED HIM TO INVESTIGATE POTENTIAL SOURCES OF CONTAMINATION, AND/OR RULE OUT CONTRIBUTING FACTORS. THE PROCEDURES WERE ALL DUODENAL SWITCHES AND GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT WAS USED ON THE DUODENAL TRANSECTION. ADDITIONAL PRODUCTS USED IN THE PROCEDURE INCLUDE AN ETHICON STAPLER, AND BAXTER PERI-STRIPS STAPLE LINE REINFORCEMENT ON THE GASTRIC POUCH. IT WAS REPORTED THERE WERE RE-OPERATIONS AND NO PRE-EXISTING INFECTION IN THE LOCATION OF THE DEVICE OR SURROUNDING ADJACENT TISSUES. REPORTEDLY, THE COLOR CARTRIDGE BEING USED WAS WHITE AND THE INFECTION DID OCCUR AT THE ANASTOMOSIS. IT WAS REPORTED THE INFECTION WAS TREATED WITH ANTIBIOTICS, A REOPERATION AND AN EGD.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 18618920 ↗

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