MAUDE Adverse Event Report: MARTECH MEDICAL PRODUCTS, INC. SOF-CURL URETERAL STENT, 6.0FR X 24CM

Model Number SSC6024

Device Problems Shipping Damage or Problem (1570); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.If the suspect device is returned for evaluation/investigation or additional significant information becomes available, this report will be supplemented accordingly.

Event Description

It was reported that during receipt inspection, the user facility received a damaged product.The box and the contents were found damaged.In addition, the customer advised they ordered a quantity of 25 and only received a quantity of 13.The customer advised that the outside of the box said 25 quantity but there was only 13 quantity.Customer explained that the outside box did not reflect as much damage as the inside box.There was no patient involvement on this event reported.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: d9,g3, g6, h2,h3, h4, h6 and h10.The returned device was evaluated.All nine devices were found in its own packaged box.All nine boxes were found smashed, water damaged, torn, dirty, smudged, etc.The device itself found in the half paper and half plastic packaging.The paper side of the packaging appeared to be water damaged (and still moist), have smudges, and wrinkled.This failure can be attributed to poor transportation.It appears that the boxes have come in contact with moisture.The moisture jeopardizes the integrity of the box (and it's contents) causing the boxes to crumble and flatten due to the weight of other boxes stacked on top.During dhr (device history record) review nothing out of specification was found.A full review of manufacturing processes was performed, nothing out of specification was found.Dhr reviewed shows that everything was done according to standard operation procedures, quality assurance procedure and customer drawing specifications.In addition, during the manufacturing boxing operation it was verified that the quantity inside the boxes matches the information printed on the label.Therefore, the work order does not show any abnormalities or rejections regarding pieces with the failure mode reported by the customer.Olympus will continue to monitor complaints for this device.

• Brand Name: SOF-CURL URETERAL STENT, 6.0FR X 24CM
• Type of Device: SOF-CURL URETERAL STENT, 6.0FR X 24CM
• Manufacturer (Section D): MARTECH MEDICAL PRODUCTS, INC.; 1500 delp drive; harleysville PA 19438
• MDR Report Key: 11421181
• MDR Text Key: 242060758
• Report Number: 3003790304-2021-00039
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00821925031678
• UDI-Public: 00821925031678
• Combination Product (y/n): N
• PMA/PMN Number: K930733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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
• Device Operator: Health Professional
• Device Model Number: SSC6024
• Device Catalogue Number: SSC6024
• Device Lot Number: MPHK660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1