MAUDE Adverse Event Report: MEDLINE RENEWAL; ASC 4250-01 SUPER TURBOVAC 90,90 DEGRE

Catalog Number	ASC425001RH
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported a piece broke off the wand and was retrieved by the physician with a grasper.Email received by facility representative, (b)(6), who provided additional information in regards to this incident.Reporter states, "incident occurred during a shoulder arthroscopy.Physician was using device and a piece of the tip broke off into the shoulder surgical site." reporter states, "dr.Was able to retrieve and remove broken piece from patients shoulder." it was reported physician used a grasper to retrieve the broken piece.Reporter states, no serious injury or follow-up care is needed.Patient is reported as having "no issues." sample has been returned for evaluation and investigational report is pending.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported a piece broke off the wand and was retrieved by the physician with a grasper.
Event or Problem Description
It was reported a piece broke off the wand and was retrieved by the physician with a grasper.
Additional Manufacturer Narrative
Supplemental documentation changed/additional information added.H5 investigation conclusion - zcd00006/unconfirmed defect.H10 investigation report reads as follows: 08/02/2021 10:03:04 cst (jwilder), investigation: "one device was received from (b)(6) center on (b)(6) 2021.The device was confirmed to be an arthrocare super turbovac90, 90 degree, suction arthrowand®, (white/grey) 3.5mm, part # asc 4250- 01.Although the medline renewal packages was not returned with the device, the lot number reported on the complaint form was 432135.Upon inspection of the device handle, it was observed that the device had two medline renewal reprocessing marks.During the investigation, the device was inspected for nonconformities per internal procedure.Upon inspection, the device was noted to have debris, indicating it had been clinically used.Upon inspection, no issues or damage to the device was observed.The reported issue was not confirmed.Root cause: the exact root cause of the device failure could not be determined.Upon inspection of the returned device, the ablation wand was observed to be intact and free of damage.Conclusions: upon inspection of the received device, the ablation wand was observed to be intact and there was no damage observed.The reported issue was not confirmed.".

• Common Device Name: ASC 4250-01 SUPER TURBOVAC 90,90 DEGRE
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 97756 1876
• MDR Report Key: 12194151
• Report Number: 3032391-2021-00014
• Device Sequence Number: 3681963
• Product Code: NUJ
• UDI-Device Identifier: 10888277380066
• UDI-Public: 10888277380066
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ASC425001RH
• Device Lot Number: 432135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 73