MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-01-16 for NCIRCLE TIPLESS STONE EXTRACTOR NTSE-022115-UDH manufactured by Cook Urological Inc.
[1017667]
This extractor broke as the basket was being pulled back through the sheath. It did have a stone in the basket at the time. The entire loop broke off and we spent hours searching for it in the body. When we did, we included the broken piece in the packaging. I made sure to ask the physician if there was resistance entering the sheath or if he felt it break? I also asked him if there were edges of the stone outside the sheath that could have caused the basket to break upon entering? His reply to all of this was no. He was really upset. He had an endourology fellowship after residency and said he has never seen a basket break this way. He said there was no feeling of being hung up. The extractor advanced smoothly into the sheath when he realized it broke.
Patient Sequence No: 1, Text Type: D, B5
[8173971]
One opened and used stone extractor was received in the open position as well as a separated wire making up half of the basket. The separated basket segment was noted to be comprised of the non-continuous shaft wires and had dried tissue covering the loop area. Upon examining the separated basket wire segment, it was observed that one end of the wire was pulled out of the cannula and the opposite end was noted to have separated just above the cannula. Upon closely examining the point of separation, the wire was noted to have an elongated/cone appearance. When viewing the distal cannula, still present on the main body of the stone extractor, it was noted to have been moved from the original location to the tip/loop area of the basket. Three of the four wires were observed inside the cannula, noting adhesive inside the cannula as well as on the three remaining wires; the complete stone extractor was returned for eval. Most likely, excessive force pulling on the basket has caused one end of the wire to separate and the opposite end of the wire to dislodge from the cannula due to inadequate adhesive applied during the mfg process. The proper dept has been notified of this occurrence. Each stone extractor is 100% inspected prior to packaging to ensure integrity.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2009-00001 |
| MDR Report Key | 1292851 |
| Report Source | 00 |
| Date Received | 2009-01-16 |
| Device Manufacturer Date | 2008-11-20 |
| Date Added to Maude | 2009-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS KILANDER |
| Manufacturer Street | 1100 WEST MORGAN ST. |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NCIRCLE TIPLESS STONE EXTRACTOR |
| Generic Name | FFD EVACUATOR, BLADDER, MANUALLY OPERATED |
| Product Code | FFD |
| Date Received | 2009-01-16 |
| Returned To Mfg | 2008-12-22 |
| Catalog Number | NTSE-022115-UDH |
| Lot Number | U1788470 |
| Device Expiration Date | 2011-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL INC |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-16 |