AESCULAP JK100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04038653202706), received between Nov 30, 2020 and Mar 3, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Flaked” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2022Structural Problem; Structural Problem

  IT WAS REPORTED TO AESCULAP AG THAT A FILTER RETENTION PLATE (PART # JK100) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE FILTER HOLDERS SPRING OFF. THE SAMPLE WAS PRODUCED IN 2006 AND REPAIRED BY MORITZ IN 2017 [MM 97/18]. ON THE BASIS OF THE GASKET, IT WAS DETERMINED THAT YARD GOODS WERE INSTALLED. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS NO DESCRIBED PATIENT HARM. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENTS: JK486 - FULL-SIZE LID W/RETENTION PLATE BLUE - LOT UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13661210 ↗
• MalfunctionNov 8, 2021Contamination; Contamination

  INVOLVED COMPONENTS: JN440 - BOTTOM F/1/1 CONT.PERFORAT.HEIGHT:90MM - LOT UNKNOWN, JN441 - BOTTOM F/1/1 CONT.PERFORAT.HEIGHT:120MM - LOT 52588251, JK441 - BOTTOM FOR 1/1 CONTAINER HEIGHT:120MM - LOT 52582372, JK489 - FULL-SIZE LID W/RETENTION PLATE SILVER - LOT 52582372, JF223R - 1/1 SIZE PERF BASKET 540X253X76MM - LOT 52685831, JF112210 - FOOT FOR PERFORATED BASKETS - LOT UNKNOWN, JK489 - FULL-SIZE LID W/RETENTION PLATE SILVER - LOT 52591143, AND JK489 - FULL-SIZE LID W/RETENTION PLATE SILVER - LOT 52631606.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775548 ↗
• MalfunctionOct 19, 2021Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH JK100 - FILTER RETENTION PLATE. ACCORDING TO THE COMPLAINT DESCRIPTION, BLACK PARTICLES WERE DETECTED. THE CUSTOMER FOUND BLACK SPECS INSIDE OF TWO RETRACTOR TRAYS. THIS WAS SUSPECTED TO BE CAUSED BY/FROM THE RETENTION PLATES. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657473 ↗
• MalfunctionDec 2, 2020Flaked; Flaked

  IT WAS REPORTED TO AESCULAP INC. THAT TWO (2) FILTER RETENTION PLATES (PART # JK100) (REF. ASSOCIATED MDR ID 9610612-2020-00836) WERE INSPECTED AFTER BEING BROUGHT TO THE OPERATING ROOM (OR) FOR USE DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, BLACK SPECKS WERE OBSERVED ON THE CONTAINER BOTTOM. REPORTEDLY, THE DEBRIS WAS NOTED ON THE CONTAINERS PERFORATED BOTTOM WITHIN THE TWO (2) CIRCULAR RETENTION PLATE AREAS. NO PATIENT COMPLICATIONS OCCURRED AND NO SURGICAL DELAY WAS EXPERIENCED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10931324 ↗
• MalfunctionNov 30, 2020Flaked; Device Contamination with Chemical or Other Material; Flaked

  IT WAS REPORTED TO AESCULAP INC. THAT TWO (2) FILTER RETENTION PLATES (PART # JK100) (REF. ASSOCIATED MDR ID 9610612-2020-00909) WERE INSPECTED AFTER BEING BROUGHT TO THE OPERATING ROOM (OR) FOR USE DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, BLACK SPECKS WERE OBSERVED ON THE CONTAINER BOTTOM. REPORTEDLY, THE DEBRIS WAS NOTED ON THE CONTAINERS PERFORATED BOTTOM WITHIN THE TWO (2) CIRCULAR RETENTION PLATE AREAS. NO PATIENT COMPLICATIONS OCCURRED AND NO SURGICAL DELAY WAS EXPERIENCED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10923675 ↗