MOXY 8632284Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207018194), received between Apr 1, 2021 and Jul 1, 2022 — classified as 1 injury, 1 malfunction.

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

• InjuryJul 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). ACCORDING TO THE USER FACILITY: "BLADDER PERFORATION WITH THE LASER WORKING INSERT. COULD NOT BE COMPLETED ENDOSCOPICALLY, URGENT LAPAROTOMY WAS PERFORMED TO REPAIR THE PATIENT'S BLADDER." THE USER FACILITY HAS NOT GIVEN INFORMATION ABOUT THE EXACT PRODUCT PROBLEM, THEY HAVE ONLY SHARED THE INFORMATION ABOUT THE HARM OF THE PATIENT. THE INVESTIGATION IS PENDING DUE TO NOT RECEIVING THE DEVICE AT RICHARD WOLF GMBH IN (B)(4). RWGMBH AWARENESS DATE, 13-JUN-2022.

  Patient problems: Insufficient Information

  MAUDE report 14887201 ↗
• MalfunctionApr 1, 2021Fracture; Difficult to Remove; Insufficient Device Problem Information; Fracture; Difficult to Remove; Insufficient Device Problem Information

  RICHARD WOLF GMBH REPORTS THAT: THE CUSTOMER SENT US THE LASER WORKING INSERT TYPE 8632.284. IN SPITE OF REPEATED REQUESTS, THE ATTACHMENT FOR CYSTOSCOPE TYPE 8650264 WAS NOT SENT TO US, SO THAT ONLY THE LASER WORKING INSERT TYPE 8632.284 COULD BE EXAMINED. THE PRESENT LASER WORKING INSERT TYPE 8632.284 ORIGINATES FROM THE BATCH: 1249546 AND WAS BOOKED TO THE NEW STOCK ON JUNE 10, 2014 WITH AN ORDER SIZE OF 15 PIECES. THE CHECK OF THE FLOW CHART DID NOT SHOW ANY ANOMALIES. THE DELIVERY TO THE CUSTOMER TOOK PLACE ON 05.11.2014. THE INSPECTION OF THE LASER WORK INSERT IN THE SPECIALIST DEPARTMENT DID NOT REVEAL ANY FUNCTIONAL DEFECT. HOWEVER, THE LASER WORK INSERT HAS CLEAR SIGNS OF USE DUE TO ITS AGE AND USE AND IS THERMALLY ATTACKED BY THE USE OF THE LASER. THE CAUSE CAN BE TRACED BACK TO USER ERROR. WITH REGARD TO SEVERAL NUMBER OF PIECES, WORLDWIDE DELIVERED WORKING INSERTS AND NO COMPARABLE COMPLAINT CASE OF THIS TYPE, A PRODUCT PROBLEM OR A MANUFACTURING PRODUCT PROBLEM OR A MANUFACTURING DEFECT CAN BE RULED OUT. THIS IS FURTHERMORE CONFIRMED BY THE FACT THAT THE PRESENT APPROACH HAS ALREADY BEEN DELIVERED FOR 7 YEARS. THUS, NO "EARLY FAILURE" DUE TO A PRODUCT DEFECT IS EVIDENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11603107 ↗