Situate L1818-04P01CN-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521706897), received between Jun 26, 2019 and Sep 23, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ORTHOPEDIC PROCEDURE, THE SPONGE RIPPED. PIECES FELL INTO PATIENT CAVITY BUT WAS RETRIEVED. NO X-RAY NOR ANY MEDICAL INTERVENTION PERFORMED TO RETRIEVE IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279557 ↗
• MalfunctionSep 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE RF TAG WAS DISLODGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179711 ↗
• MalfunctionNov 16, 2022Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS COTTON/LINT ON LAPAROTOMY SPONGES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15808124 ↗
• MalfunctionNov 14, 2022Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, COTTON/LINT FOUND ON LAP SPONGE.

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

  MAUDE report 15789010 ↗
• MalfunctionJan 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S RF (RADIO FREQUENCY) SENSOR FELL OUT. THE SURGEON NOTED THAT DURING CLOSURE OF ABDOMINAL INCISION SITES THAT THERE WAS A SMALL ITEM ON THE HEAD BUTLER TRAY (TRAY USED TO HOLD SURGICAL INSTRUMENTS ABOVE THE PATIENT HEAD). IT WAS IMMEDIATELY REMOVED FROM FIELD AND IDENTIFIED BY SURGICAL TECH AND RN (REGISTERED NURSE) AS THE INDICATOR FROM THE RADIO FREQUENCY SURGICAL SPONGE. SPONGES THAT HAD BEEN USED WERE PALPATED AND ONE WAS FOUND HAVE A MISSING INDICATOR. IT WAS PULLED FROM RED BUCKET AND BAGGED WITH INDICATOR. WRAPPER FROM BACK TABLE PACK WITH LOT NUMBER WAS RECOVERED AND ITEMS LABELED WITH PATIENT STICKER TO BETAKEN TO MATERIALS MANAGER. NURSE MANAGER WAS INFORMED. RN SPOKE TO SURGICAL TEAM AND ALL AGREED THAT X-RAY WAS NOT INDICATED AS ALL WERE CONFIDENT ALL PIECES WERE ACCOUNTED FOR. WAND SCAN CONFIRMED NO RETAINED SPONGES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11200800 ↗
• MalfunctionSep 10, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, BOTH GAUZE WERE SHREDDING AND FALLING APART. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8984793 ↗
• MalfunctionSep 10, 2019Contamination; Material Fragmentation; Contamination; Material Fragmentation

  ACCORDING TO THE REPORTER, THE TWO SPONGES WERE SHREDDING AND FALLING APART.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8984406 ↗
• MalfunctionAug 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THERE WAS A GREEN STRING RELEASE FROM THE DEVICE. THE STRING FOUND ON THE TOWEL IN PACK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 8911609 ↗
• MalfunctionJun 26, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING ANTERIOR HIP CASE, THE DEVICE'S STRING GOT DETACHED FROM LAP SPONGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733346 ↗