WECK IPN008820 (REF 528236)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 34026704630302), received between Apr 27, 2021 and Oct 4, 2021 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  STAPLES COME OFF AFTER TWO DAYS AND ARE DIFFICULT TO PLACE IN THE STAPLER THERE IS A RISK FOR THE PATIENT (INFECTION).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568901 ↗
• MalfunctionOct 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  STAPLES COME OFF AFTER TWO DAYS AND ARE DIFFICULT TO PLACE IN THE STAPLER, THERE ARE A RISK FOR THE PATIENT (INFECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568846 ↗
• MalfunctionOct 4, 2021Failure to Form Staple; Activation, Positioning or Separation Problem; Failure to Form Staple; Activation, Positioning or Separation Problem

  THE STAPLES OF THE SKIN STAPLER CLOSED INCORRECTLY SO THAT THEY DO NOT FIT PROPERLY ON THE PATIENT'S SKIN. THERE WAS NO MEDICAL COMPLICATION AND NO TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568230 ↗
• MalfunctionOct 4, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  STAPLES COME OFF AFTER TWO DAYS AND ARE DIFFICULT TO PLACE IN THE STAPLER, THERE ARE A RISK FOR THE PATIENT(INFECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568191 ↗
• MalfunctionOct 4, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  STAPLES COME OFF AFTER TWO DAYS AND ARE DIFFICULT TO PLACE IN THE STAPLER, THERE IS A RISK FOR THE PATIENT(INFECTION).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568167 ↗
• MalfunctionOct 4, 2021Failure to Form Staple; Activation, Positioning or Separation Problem; Failure to Form Staple; Activation, Positioning or Separation Problem

  THE STAPLES OF THE SKIN STAPLER CLOSED INCORRECTLY SO THAT THEY DO NOT FIT PROPERLY ON THE PATIENT'S SKIN. THERE WAS NO MEDICAL COMPLICATION AND NO TREATMENT REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568069 ↗
• MalfunctionJun 14, 2021Break; Break

  CERTIFIED SURGICAL TECHNICIAN WAS ATTEMPTING TO STAPLE THE STERILE DRAPES TOGETHER AND THE STAPLER THAT CAME IN THE ORTHO/TRAUMA PACK FELL APART AFTER THE FIRST USE. THE STAPLE CARTRIDGE COMPLETELY FELL OUT, AS DID ALL THE STAPLES ON TOP OF THE PATIENT. SURGICAL SITE WAS THE LEFT ELBOW, AND NOT NEAR THE MALFUNCTION. NO KNOWN INJURY TO PATIENT, BUT LOOSE STAPLES WERE COLLECTED AS MUCH AS POSSIBLE TO PREVENT ANY POSSIBLE INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992816 ↗
• MalfunctionJun 14, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  STAPLER DO NOT CLOSE THE CLAMPS OR DO NOT CLAMP THEM AT ALL. THIS PROBLEM WAS IDENTIFIED WHEN THE STAPLER WAS TO BE USED. HOWEVER, SINCE IT DID NOT WORK, A REPLACEMENT PRODUCT HAD TO BE USED. THIS INCIDENT HAPPENED IN 4 TRAYS, SO 4 STAPLERS WERE PROBLEMATIC. THERE WAS NO ADVERSE EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992665 ↗
• MalfunctionJun 14, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  STAPLER DO NOT CLOSE THE CLAMPS OR DO NOT CLAMP THEM AT ALL. THIS PROBLEM WAS IDENTIFIED WHEN THE STAPLER WAS TO BE USED. HOWEVER, SINCE IT DID NOT WORK, A REPLACEMENT PRODUCT HAD TO BE USED. THIS INCIDENT HAPPENED IN 4 TRAYS, SO 4 STAPLERS WERE PROBLEMATIC. THERE WAS NO ADVERSE EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992618 ↗
• MalfunctionJun 14, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  STAPLER DO NOT CLOSE THE CLAMPS OR DO NOT CLAMP THEM AT ALL. THIS PROBLEM WAS IDENTIFIED WHEN THE STAPLER WAS TO BE USED. HOWEVER, SINCE IT DID NOT WORK, A REPLACEMENT PRODUCT HAD TO BE USED. THIS INCIDENT HAPPENED IN 4 TRAYS, SO 4 STAPLERS WERE PROBLEMATIC. THERE WAS NO ADVERSE EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992586 ↗
• MalfunctionJun 14, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  STAPLER DO NOT CLOSE THE CLAMPS OR DO NOT CLAMP THEM AT ALL. THIS PROBLEM WAS IDENTIFIED WHEN THE STAPLER WAS TO BE USED. HOWEVER, SINCE IT DID NOT WORK, A REPLACEMENT PRODUCT HAD TO BE USED. THIS INCIDENT HAPPENED IN 4 TRAYS, SO 4 STAPLERS WERE PROBLEMATIC. THERE WAS NO ADVERSE AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992547 ↗
• MalfunctionJun 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  STAPLER LOST STAPLES, WHILE BEING USED FELL FROM STAPLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968593 ↗
• MalfunctionApr 27, 2021Failure to Form Staple; Failure to Form Staple

  WE HAVE RECEIVED COMPLAINTS AFTER CHANGING SKIN STAPLER FROM COVIDEN TO TELEFLEX. THE CLAMPS DO NOT ADHERE IN THE SUBCUTANEOUS LAYER. IT DOES NOT LOCK AS IT SHOULD. HAVE HAPPENED TO MANY TIMES AND THE CUSTOMER WANT FINANCIAL REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731763 ↗
• MalfunctionApr 27, 2021Failure to Form Staple; Failure to Form Staple

  WE HAVE RECEIVED COMPLAINTS AFTER CHANGING SKIN STAPLER FROM COVIDEN TO TELEFLEX. THE CLAMPS DO NOT ADHERE IN THE SUBCUTANEOUS LAYER. IT DOES NOT LOCK AS IT SHOULD. HAVE HAPPENED TO MANY TIMES AND THE CUSTOMER WANTS FINANCIAL REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731695 ↗