NA 72201693Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010605269), received between Oct 1, 2018 and Apr 29, 2019 — classified as 7 injuries.

The most frequently reported specific device problem is “Scratched Material” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2019Break; Scratched Material

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPIC SURGERY, THE MEDIUM FLOW CANNULA GET A SHARP EDGE, CAUSING A POTENTIALLY CARTILAGE DAMAGE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE AND NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8562312 ↗
• InjuryApr 29, 2019Sharp Edges

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPIC SURGERY, THE MEDIUM FLOW CANNULA GET A SHARP EDGE, CAUSING A POTENTIALLY CARTILAGE DAMAGE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE AND NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562304 ↗
• InjuryDec 27, 2018Scratched Material; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING AN SHOULDER ARTHROSCOPY, THE PATIENT SUFFERED CARTILAGE DAMAGES IN THE HUMERUS AS A CONSEQUENCE OF AN EXISTING GAP BETWEEN THE 5.00 MM CANNULA TIP-END (WHICH HAS A SHARP EDGE) AND THE ARTHROSCOPE WHEN CONNECTED. AS THIS ADVERSE CONSEQUENCE WAS NOTICED AFTER THE PROCEDURE, THE SURGERY HAD BEEN FINISHED WITH THE SAME DEVICE, IN A TIMELY MANNER. IT IS STILL UNKNOWN: (I) THE OUTCOME AND EVOLUTION OF THE PATIENT; AND (II) IF THERE WAS ANY NECESSARY REVISION SURGICAL INTERVENTION TO PRECLUDE ANY PERMANENT DAMAGE TO THE CARTILAGE.

  Patient problems: Tissue Damage

  MAUDE report 8201123 ↗
• InjuryDec 27, 2018Scratched Material; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING AN SHOULDER ARTHROSCOPY, THE PATIENT SUFFERED CARTILAGE DAMAGES IN THE HUMERUS AS A CONSEQUENCE OF AN EXISTING GAP BETWEEN THE 5.00 MM CANNULA TIP-END (WHICH HAS A SHARP EDGE) AND THE ARTHROSCOPE WHEN CONNECTED. AS THIS ADVERSE CONSEQUENCE WAS NOTICED AFTER THE PROCEDURE, THE SURGERY HAD BEEN FINISHED WITH THE SAME DEVICE, IN A TIMELY MANNER. IT IS STILL UNKNOWN: (I) THE OUTCOME AND EVOLUTION OF THE PATIENT; AND (II) IF THERE WAS ANY NECESSARY REVISION SURGICAL INTERVENTION TO PRECLUDE ANY PERMANENT DAMAGE TO THE CARTILAGE.

  Patient problems: Tissue Damage

  MAUDE report 8201092 ↗
• InjuryDec 27, 2018Scratched Material

  IT WAS REPORTED THAT, DURING AN SHOULDER ARTHROSCOPY, THE PATIENT SUFFERED CARTILAGE DAMAGES IN THE HUMERUS AS A CONSEQUENCE OF AN EXISTING GAP BETWEEN THE 5.00 MM CANNULA TIP-END (WHICH HAS A SHARP EDGE) AND THE ARTHROSCOPE WHEN CONNECTED. AS THIS ADVERSE CONSEQUENCE WAS NOTICED AFTER THE PROCEDURE, THE SURGERY HAD BEEN FINISHED WITH THE SAME DEVICE, IN A TIMELY MANNER. IT IS STILL UNKNOWN: (I) THE OUTCOME AND EVOLUTION OF THE PATIENT; AND (II) IF THERE WAS ANY NECESSARY REVISION SURGICAL INTERVENTION TO PRECLUDE ANY PERMANENT DAMAGE TO THE CARTILAGE.

  Patient problems: Tissue Damage

  MAUDE report 8201054 ↗
• InjuryDec 27, 2018Positioning Problem

  IT WAS REPORTED THAT, DURING AN SHOULDER ARTHROSCOPY, THE PATIENT SUFFERED CARTILAGE DAMAGES IN THE HUMERUS AS A CONSEQUENCE OF AN EXISTING GAP BETWEEN THE 5.00 MM CANNULA TIP-END (WHICH HAS A SHARP EDGE) AND THE ARTHROSCOPE WHEN CONNECTED. AS THIS ADVERSE CONSEQUENCE WAS NOTICED AFTER THE PROCEDURE, THE SURGERY HAD BEEN FINISHED WITH THE SAME DEVICE, IN A TIMELY MANNER. IT IS STILL UNKNOWN: (I) THE OUTCOME AND EVOLUTION OF THE PATIENT; AND (II) IF THERE WAS ANY NECESSARY REVISION SURGICAL INTERVENTION TO PRECLUDE ANY PERMANENT DAMAGE TO THE CARTILAGE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8201001 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SURGEON GOT A CARTILAGE DAMAGE ON HUMERUS WHEN HE WAS ACCESSING THE SHOULDER WITH THE CANNULA AND ARTHROSCOPE. A BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE AND THERE WAS NOT A DELAY REPORTED.

  Patient problems: Injury

  MAUDE report 7923017 ↗