NA 60-6045-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30653405038256), received between Mar 24, 2016 and Mar 24, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

22 other recalls cover devices cleared under the same FDA submission (K943327); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2016Detachment Of Device Component

  THE USER FACILITY REPORTED THAT DURING USE OF A FENESTRATED GRASPER, 5MM X 33CM LENGTH, IN A LAPAROSCOPIC CHOLECYSTECTOMY AND AT THE MOMENT OF THE INTRODUCTION OF THE DEVICE THROUGH THE TROCAR, THE BLACK PLASTIC COVER (INSULATION) ON THE DEVICE SHAFT DETACHED AND FELL INTO THE PATIENT'S PERITONEAL CAVITY. THE INSULATION WAS IMMEDIATELY RETRIEVED FROM THE PERITONEAL CAVITY AND REMOVED. THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO FURTHER COMPLICATIONS OR INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5524473 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K943327. One submission often covers many models, so check the product and lot details in each record.

• Z-0105-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Allis Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-006. --- The product is distributed sterile in heat-sealed tray and labeled
• Z-0103-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-004. --- The product is distributed sterile in heat-sealed tray
• Z-0100-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Endoweave Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-435. --- The product is distributed sterile in heat-sealed tray and label
• Z-0097-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6045-002. --- The product is distributed sterile in heat-sealed tray
• Z-0108-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-432. --- The product is distributed sterile in heat-sealed tr
• Z-0095-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 33cm length, REF/Product Code 60-6047-001. --- The product is distributed sterile in heat-sealed tray and labeled
• Z-0114-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Meeker (Right Angle) Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-434. --- The product is distributed sterile in heat-sealed tr
• Z-0107-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Dissector, 5mm x 33cm length, REF/Product Code 60-6040-002. --- The product is distributed sterile in heat-sealed t
• Z-0102-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-433. --- The product is distributed sterile in heat-sealed tr
• Z-0110-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Endoweave Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-435. --- The product is distributed sterile in heat-sealed tray and labe
• Z-0096-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6047-431. --- The product is distributed sterile in heat-sealed tray and labeled
• Z-0094-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Allis Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-436. --- The product is distributed sterile in heat-sealed tray and labeled wi
• Z-0098-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Curved ''Maryland'' Disposable Grasper, 5mm x 43cm length, REF/Product Code 60-6045-432. --- The product is distributed sterile in heat-sealed tray
• Z-0106-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Allis Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-436. --- The product is distributed sterile in heat-sealed tray and labeled
• Z-0112-2007 · Oct 12, 2006 · Terminated
  ConMed Laparoscopic Instrument: Fenestrated (Duckbill) Disposable Dissector, 5mm x 43cm length, REF/Product Code 60-6040-433. --- The product is distributed sterile in heat-sealed

…and 7 more.