MAUDE Adverse Event Report: MEDLINE RENEWAL; ASC 4630-01 @TRISTAR 50 SUCTION ARTHROW&

Catalog Number ASC463001RH

Device Problems Material Separation (1562); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that during an unidentified procedure, a renewal reprocessed arthrocare ablation wand was being used and the tip of the wand broke off inside of the patient.The reporting facility states, "the broken tip and debris were successfully removed from the patient." no information has been provided related to how the wand tip or debris was retrieved from the surgical site.No adverse impact to the procedure or the patient has been reported.No sample was returned for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the tip of a reprocessed arthrocare ablation wand fell off in the surgical site during a procedure.

• Type of Device: ASC 4630-01 @TRISTAR 50 SUCTION ARTHROW&
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond, or
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 10446158
• MDR Text Key: 206364789
• Report Number: 3032391-2020-00006
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASC463001RH
• Device Lot Number: 433844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 83