ENDOPATH EPS06Recalls & reported problems
Ethicon Endo-Surgery, LLC · Endopath Electrosurgery Probe Plus II 5mm Spatula Monopolar Electrosurgery Suction and Irrrigation Shafts with Spatula Electrode - Use only with Probe Plus II Handles · Class 2
Quick summary
This Ethicon Endopath electrosurgery probe is a slim surgical tool used to cut tissue with electric current during keyhole surgery. The 30 reports mostly describe packaging mix-ups with the wrong tip inside, devices that did not deliver energy, and tips bending or breaking, including one where a tip was left in the patient. The reports mention no deaths and 1 injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705036012504), received between Oct 12, 2018 and Feb 9, 2024 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (22 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.
Reports received per month
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem22
- Device Markings/Labelling Problem19
- Arcing of Electrodes3
- Detachment of Device or Device Component2
- Appropriate Device Problem Term/Code Not Available1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Consequences Or Impact To Patient3
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2024Arcing of Electrodes; Arcing of Electrodes
IT WAS REPORTED THAT, DURING AN OB-GYN PROCEDURE, THE DEVICES DID NOT ENERGIZE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18675558 ↗InjurySep 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, ON (B)(6) 2020, THE DEVICE WAS USED FOR GIANT FIBROIDS IN AN OB-GYN PROCEDURE. SINCE THE BLADES WOULD BEND UNDER LOAD, ABOUT FIVE OF THEM WERE REPLACED WITH OTHER DEVICES WHILE BEING USED. RECENTLY, WHEN X-RAYS WERE TAKEN AT ANOTHER ORTHOPEDIC CLINIC, A SPATULA-SHAPED TIP WAS FOUND LEFT IN THE BODY, AND WHEN CONFIRMED, IT TURNED OUT TO BE THE TIP OF A SPATULA. THE PATIENT (A WOMAN) IS CURRENTLY OUT OF THE HOSPITAL, AND IT SEEMS THAT THE ELECTRODE AT THE TIP OF THE EPS06 REMAINS IN THE BODY. THE SURGEON COMMENTED THAT IT IS TRUE THAT IT WAS OVERLOADED WITH A HUGE FIBROID. THEREFORE, THE OPERATION WAS PERFORMED WHILE REPLACING ABOUT 5 DEVICES WITH OTHER DEVICES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 17744384 ↗MalfunctionFeb 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE SHAFT WAS BROKEN DURING PRE-RUN TEST. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16329629 ↗MalfunctionJun 22, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE THE WRONG DEVICE WAS INSIDE THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14779019 ↗MalfunctionJun 22, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE THE WRONG DEVICE WAS INSIDE THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14778956 ↗MalfunctionJun 22, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE THE WRONG DEVICE WAS INSIDE THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14778707 ↗MalfunctionMay 13, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE THE EPS06'S INSIDE THE PACKAGE ARE A HOOK AND NOT A SPATULA. THEY WENT BACK AND OPENED WHAT WAS NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14401202 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731802 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731783 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731771 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731731 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731720 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731697 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731686 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731672 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731634 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731614 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731585 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731550 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731541 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731519 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731504 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731486 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731472 ↗MalfunctionMar 11, 2022Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem; Device Markings/Labelling Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE CUSTOMER ORDERED PROBES WITH SPATULA, BUT THE PRODUCTS THAT ARRIVED WERE PROBE HOOKS. THE PACKAGING SAYS SPATULA, BUT THE PRODUCT INSIDE IS HOOK. CUSTOMER DID NOT DISCOVER THIS UNTIL THEY OPENED THE PACKAGE PRIOR TO THE CASE. CUSTOMER STATES THAT THEY USED THE DEVICE WITHOUT ISSUE AND THERE WAS NO APPARENT CONSEQUENCE TO PATIENT. HOWEVER, GIVEN THE MISMATCHED PACKAGING AND POTENTIAL SAFETY CONCERNS, THEY WOULD LIKE REPLACEMENT PRODUCTS (SPATULA). NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13731464 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.