NA 4170956Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04055207048641), received between Feb 26, 2021 and Mar 2, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2023Decrease in Suction; Decrease in Suction

  A USER FACILITY REPRESENTATIVE REPORTS AN ISSUE REGARDING SUCT./IRRIG.TUBE SET SPIKE L 3M PVC PART NO. 4170956 WITH LOT NO. 32224432. THE REPRESENTATIVE REPORTED THAT THE TUBE FOR SUCTION COLLAPSES AND CANNOT BE FIXED. IT CANNOT SUCTION LARGE AMOUNTS OR THICKER AMOUNTS OF FLUID. THEY WOULD HAVE TO OPEN THE PATIENT UP IN ORDER TO SUCTION PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 16471103 ↗
• MalfunctionOct 24, 2022Decrease in Suction; Decrease in Suction

  RWGMBH REFERENCE COMPLAINT NO. (B)(4). ON (B)(6) 2021 RICHARD WOLF GMBH (RW GMBH) WAS NOTIFIED BY A CANADIAN DISTRIBUTOR THAT A CUSTOMER'S 4170956 SUCTION-IRRIGATION TUBE SET WITH PIERCING SPIKE APPEARED TO HAVE COLLAPSED RESULTING IN POOR OR NO SUCTION. THE USER HAD TO MANUALLY MANIPULATE THE TUBING SET TO MAINTAIN SUCTION. SINCE, ACCORDING TO THE CUSTOMER, THE APPLICATION COULD BE COMPLETED WITHOUT PATIENT INJURY OR SURGICAL DELAYS, THE DECISION WAS MADE ON (B)(6) 2022, THAT IT WAS NOT REPORTABLE AND THE CASE WAS CLASSIFIED AS A COMPLAINT. THE COMPLAINT WAS CLOSED ON (B)(6) 2022. ON (B)(6) 2022, RW GMBH WAS REQUESTED BY THE CANADIAN AUTHORITY TO SUBMIT A STATEMENT ON THIS CASE, SO THAT COMPLAINT (B)(4) WAS REOPENED AND CLASSIFIED AS A VIGILANCE CASE. RWGMBH MDR AWARENESS DATE:(B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15660223 ↗
• MalfunctionMar 24, 2021Material Separation; Material Separation

  THE DEVICE WAS RECEIVED AND EVALUATED BY RW GMBH. THE RESULTS: DURING THE INSPECTION, IT WAS FOUND THAT THE TIP OF ONE OF THE PIERCING MANDRELS ON A SUCT./IRRIG.TUBE SET SPIKE L 3M HAD BROKEN OFF. THE CAUSE OF THE BROKEN TIP IS THEREFORE DUE TO MECHANICAL OVERLOAD. THE FRACTURE PATTERN AS WELL AS THE ADJACENT REGIONS SHOW NO SIGNS OF A MATERIAL OR PRODUCTION DEFECT. THE PRODUCTION RECORD OF THE AFFECTED BATCH HAS BEEN CHECKED AND DOES NOT SHOW ANY DEVIATIONS RELEVANT TO THIS CASE OF ERROR. THE USER IS EXPRESSLY ADVISED IN THE ENCLOSED INSTRUCTIONS FOR USE (GA-B145) THAT A VISUAL INSPECTION MUST ALWAYS BE CARRIED OUT BEFORE AND AFTER USE. THIS INSPECTION MUST CHECK WHETHER THE INSTRUMENT AND ACCESSORIES ARE DAMAGED OR INCOMPLETE OR HAVE LOOSE PARTS OR MISSING PARTS. REFERENCE IS ALSO MADE TO A FUNCTIONAL CHECK TO BE PERFORMED AND THE LIMITED STABILITY OF THE PRODUCTS. NO MISSING PARTS MAY REMAIN IN THE PATIENT. PRODUCTS THAT ARE DAMAGED AND/OR INCOMPLETE OR HAVE LOOSE PARTS MUST NO LONGER BE USED. BASED ON THE AVAILABLE TEST RESULTS, WE ASSUME THAT THERE WAS A HANDLING ERROR. THE PIERCING MANDRELS ON THE TUBE SET WERE MECHANICALLY OVERLOADED. THE HOSE SET 4170,956 HAS BEEN IN THE SA

  Patient problems: Foreign Body In Patient

  MAUDE report 11560429 ↗
• MalfunctionFeb 26, 2021Suction Problem; Suction Problem

  THE DEVICE WAS NOT SENT IN BY THE USER, THEREFORE NO INVESTIGATION COULD BE CARRIED OUT. PLEASE SEE MANUFACTURERS NARRATIVE FOR PRODUCT HISTORY EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 11387819 ↗