MAUDE Adverse Event Report: QUICKLINK SDSLINK #10 SAMPLES; BRACHYTHERAPY LINKS & CARTRIDGES

Model Number	70302QC10
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a lot number for the device was reported to be unknown.However, a device history record review was performed for the affected lot number of the cartridge and this lot meets all release criteria.Investigation summary: one 70302qc10 quicklink sdsdlink cartridge with 10 seed to seed links, was returned from the customer for evaluation and was labeled as biohazardous.Upon initial inspection, the cartridge gate closure worked as expected.No spring protrusions were noticed on the backside of the cartridge.The plunger was pulled back and traveled appropriate.Tweezers were used to try to separated the links and no issues were noted.The links were in great shape.The cartridge was inserted into quicklink loader (sn #(b)(4)) and all 10 links dispensed as expected.Upon completion of dispensing, the cartridge was removed from the loader and examined.No issues noted.The investigation for the reported issue is unconfirmed.A definitive root cause could not be determined based upon available information.Labeling review: labeling was reviewed and found to be adequate.The information for use which states "in the event the quicklink¿ loader or cartridges become inoperable due to damage or malfunction, any or all components may be removed from the cartridges and implanted manually.".
Event or Problem Description
It was reported that during a brachytherapy procedure, the connector allegedly could not be discharged although the connector was set correctly on the loader.There was no reported patient injury.

• Brand Name: QUICKLINK SDSLINK #10 SAMPLES
• Common Device Name: BRACHYTHERAPY LINKS & CARTRIDGES
• MDR Report Key: 12547689
• Report Number: 1018233-2021-06081
• Device Sequence Number: 19841516
• Product Code: KXK
• UDI-Device Identifier: 10801741078092
• UDI-Public: (01)10801741078092
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2021

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 Model Number: 70302QC10
• Device Catalogue Number: 70302QC10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1