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ReNew 3352Recalls & reported problems

Microline Surgical, Inc. · Traditional Maryland Dissector Tip, Disposable · Class 2

All models of ReNew (45)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00811099010135), received between May 18, 2018 and Jun 29, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

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 16, 2026.

Most reported problems

Device problems

  • Fracture1
  • Insufficient Device Problem Information1
  • Material Deformation1
  • Material Fragmentation1
  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJun 29, 2023Material Fragmentation; Material Fragmentation

    SLEEVE NOTED IN ABDOMEN AT TIME IT FELL OFF HANDLE, TIP REPORTED TO HAVE BEEN TIGHTENED TO INSTRUMENT PRE-OPERATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17226161 ↗
  • MalfunctionAug 25, 2021Fracture; Fracture

    DURING A LAPAROSCOPIC TEP/HERNIA PROCEDURE, THE HEAT SHRINK DETACHED AND FELL INTO EXTRA PERITONEAL SPACE. EXTENDED OP TIME BECAUSE ONE HAD TO SEARCH/FIND AND GET OUT THE DETACHED PART.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12364358 ↗
  • MalfunctionFeb 8, 2019Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

    PROTECTIVE SLEEVE ON TIP CAME OFF DURING PROCEDURE AND HAD TO BE REMOVED FROM PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8322180 ↗
  • MalfunctionMay 18, 2018Material Separation; Material Separation

    WHILE PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON NOTICED THAT THE HEAT-SHRINK ON THE RENEW TRADITIONAL MARYLAND DISSECTOR FORCEPS TIP WAS NO LONGER THERE. THE HEAT-SHRINK FELL OFF THE TIP INTO THE PATIENT. THE SURGEON AND THE SCRUB NURSE WERE ABLE TO LOCATE THE ENTIRE HEAT-SHRINK PIECE AND RETRIEVE IT. THE PROCEDURE AND ANESTHESIA TIME WERE NOT EXTENDED. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7526194 ↗

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Sources and updates

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