NA 2598-07-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295148258), received between Jan 19, 2022 and May 8, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Peeled/Delaminated

  IT WAS REPORTED THAT ANTERIOR APPROACH CASE COMPL HAD A PEELING PAN THAT REQUIRES REPLACEMENT. THERE WAS NO REPORTED PATIENT OR USER HARM, AND NO SIGNIFICANT DELAY WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122511 ↗
• MalfunctionMay 23, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT ANTERIOR APPROACH CASE COMPL HAS SIGNS OF WORN OUT, HAS MISSING THE MAT SILICONE GREY OF THE BASE, ADDITIONALLY THE PLASTIC COVER START PEELING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381552 ↗
• MalfunctionMay 23, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT ANTERIOR APPROACH CASE COMPL HAS SIGNS OF WORN OUT, HAS MISSING THE MAT SILICONE GREY OF THE BASE, ADDITIONALLY THE PLASTIC COVER START PEELING OFF AND WAS BROKEN FROM ONE PORTION OF THE LID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19381549 ↗
• MalfunctionMay 15, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT ANTERIOR APPROACH CASE COMPL HAS SIGNS OF WORN OUT, HAS MISSING THE MAT SILICONE GREY OF THE BASE, ADDITIONALLY THE PLASTIC COVER STARTED PEELING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323498 ↗
• MalfunctionMay 15, 2024No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT. ADDITIONAL EVENT INFORMATION: VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT ANTERIOR APPROACH CASE COMPL HAS SIGNS OF WORN OUT, HAS MISSING THE MAT SILICONE GREY OF THE BASE, ADDITIONALLY THE PLASTIC COVER STARTED PEELING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323497 ↗
• MalfunctionMar 27, 2024Peeled/Delaminated; Scratched Material; Peeled/Delaminated; Scratched Material

  ADDITIONAL INFORMATION N RECEIVED: A. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO C. CAN YOU PLEASE CLARIFY WHAT DO YOU MEAN BY ¿DAMAGED¿? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. GOUGE IN BLOCK. D. EVENT DESCRIPTION STATES THAT "CUT BLOCK UNABLE TO USE DUE TO SURFACE DAMAGE." PLEASE CLARIFY WHAT YOU MEAN BY DAMAGED. WAS IT BROKE, CRACKED, BENT OR ANY OTHER DEFICIENCY WITH THE DEVICE THAT WAS NOT FUNCTION AS INTENDED? DEEP LACERATIONS.

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

  MAUDE report 18985645 ↗
• MalfunctionMar 18, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE TRAYS ARE CHIPPING FLAKES OFF. THE HOSPITAL IS DEEMING THEM CONTAMINATED AFTER STERILE PROCESS AND UNFIT FOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924960 ↗
• MalfunctionMar 18, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE TRAYS ARE CHIPPING FLAKES OFF. THE HOSPITAL IS DEEMING THEM CONTAMINATED AFTER STERILE PROCESS AND UNFIT FOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924943 ↗
• MalfunctionMar 18, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE TRAYS ARE CHIPPING FLAKES OFF. THE HOSPITAL IS DEEMING THEM CONTAMINATED AFTER STERILE PROCESS AND UNFIT FOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924623 ↗
• MalfunctionMar 18, 2024Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE TRAYS ARE CHIPPING FLAKES OFF. THE HOSPITAL IS DEEMING THEM CONTAMINATED AFTER STERILE PROCESS AND UNFIT FOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924619 ↗
• MalfunctionMar 7, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THIS EVENT INCLUDED TRAYS BEING REJECTED DUE TO INTEGRITY CONCERNS OF THE INSIDE OF THE TRAYS WHICH RESULTED IN SMALL BACK SPECKS BEING OBSERVED AT THE BOTTOM OF THE TRAYS UPON OPENING THE TRAYS FOR A SURGICAL PROCEDURE. THE CONTAMINATION OF THE TRAYS INCLUDED PRIMARY TRAYS AND BACK-UP TRAYS AND RESULTED IN A CASE CANCELLATION DUE TO NOT HAVING THE APPROPRIATE TRAYS TO PROCEED WITH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18855142 ↗
• MalfunctionFeb 21, 2024Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT THE ANTERIOR APPROACH INSTRUMENT PAN COATING WAS WORN, HAS SHARP EDGES THAT HOSPITAL BELIEVES WAS PUTTING HOLES IN STERILE WRAP. GRAPHIC CONTAINER NEEDS REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18749134 ↗
• MalfunctionDec 18, 2023Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION WAS RECEIVED: NO IMMEDIATE CONSEQUENCES TO PATIENTS, BESIDES LACK OF INSTRUMENTS BECAUSE TRAYS WERE DEEMED ¿UNSTERILE¿. POTENTIALLY CAUSING CASES TO BE CANCELLED. DATE WAS MENTIONED ON SUBMISSION. DEC 8TH. I DO NOT HAVE LOT NUMBER INFORMATION. (ALL TRAYS EXPERIENCING THIS COMPLAINT) WILL RETURN WHEN AT ACCOUNT NEXT AND PROVIDE SHIPPING. MAY REQUIRE REPLACEMENT TRAYS PRIOR TO PULLING DAMAGED TRAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344170 ↗
• MalfunctionDec 18, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT INSTRUMENT TRAYS ARE BREAKING DOWN. BLACK PLASTIC COATING FLAKING OFF. DID THE EVENT OCCUR DURING STERILE PROCESSING? YES, DID THE EVENT OCCUR DURING FIELD INSPECTION? YES, DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344152 ↗
• MalfunctionDec 18, 2023Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION WAS RECEIVED: NO IMMEDIATE CONSEQUENCES TO PATIENTS, BESIDES LACK OF INSTRUMENTS BECAUSE TRAYS WERE DEEMED ¿UNSTERILE¿. POTENTIALLY CAUSING CASES TO BE CANCELLED. DATE WAS MENTIONED ON SUBMISSION. DEC 8TH. I DO NOT HAVE LOT NUMBER INFORMATION. (ALL TRAYS EXPERIENCING THIS COMPLAINT) WILL RETURN WHEN AT ACCOUNT NEXT AND PROVIDE SHIPPING. MAY REQUIRE REPLACEMENT TRAYS PRIOR TO PULLING DAMAGED TRAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344143 ↗
• MalfunctionDec 18, 2023Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION WAS RECEIVED: 1. NO IMMEDIATE CONSEQUENCES TO PATIENTS, BESIDES LACK OF INSTRUMENTS BECAUSE TRAYS WERE DEEMED ¿UNSTERILE¿. POTENTIALLY CAUSING CASES TO BE CANCELLED. 2. DATE WAS MENTIONED ON SUBMISSION. DEC 8TH. 3. I DO NOT HAVE LOT NUMBER INFORMATION. (ALL TRAYS EXPERIENCING THIS COMPLAINT) WILL RETURN WHEN AT ACCOUNT NEXT AND PROVIDE SHIPPING. MAY REQUIRE REPLACEMENT TRAYS PRIOR TO PULLING DAMAGED TRAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344105 ↗
• MalfunctionDec 7, 2023Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION RECEIVED FROM SALES REP: A. NO DELAY. B. NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282409 ↗
• MalfunctionJan 19, 2022Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  ANTERIOR APPROACH RETRACTORS PAN HAS A SHARP PIECE ON THE BOTTOM AND IT¿S TEARING THE STERILE WRAP. THE PLASTIC COATING WHERE THE DIVIDERS CONNECT ON THE BOTTOM OF THE PAN HAS COME OFF. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13290228 ↗