MAUDE Adverse Event Report: ELEKTA INC. (NUCLETRON B.V.) SMIT SLEEVE; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number 189565-00

Device Problem Expiration Date Error (2528)

Patient Problem No Information (3190)

Event Date 10/03/2017

Event Type  malfunction  

Event Description

Surgeon brought implant, smit sleeve t-mr brachytherapy, to operating room to insert into patients vagina.The nurse checked package along with expiration date.Expiration date read, 2015-12.Nurse stated to surgeon that the item brought was expired.Surgeon contacted another physician who supplied the smit sleeve, via phone call.Physician contacted insisted that this type of implant does not expire.Surgeon opened package and continued to use the item.

• Brand Name: SMIT SLEEVE
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): ELEKTA INC. (NUCLETRON B.V.); 400 perimeter center ter ne suite 50; atlanta GA 30346
• MDR Report Key: 7876233
• MDR Text Key: 120252441
• Report Number: 7876233
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 189565-00
• Device Lot Number: 104479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2018
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Weight: 89