MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2007-09-24 for ECHOTIP DISPOSABLE LANCET NEEDLE J-DSN-181501 manufactured by Cook Urological.
[21611176]
Customer states: "interstitial laser procedure for selective reduction of triplets (mono chorionic pair). This procedure has been done for the last 6 years with this needle. The tip broke off. The procedure is where the needle is inserted into the uterus and then into the cord insertion (fetal abdomen) then the stylet is removed and the laser fiber is threaded down the needle 2-3mm distal to the tip of the needle and then the laser is fired. This laser is fired 3-4 times to occlude the cord for one of the twins (3 to 2 reduction). The procedure was straight forward and then the laser fibre was removed then the needle was removed there was resistance at the skin and normally there is some charring at the tip of the needle but in this case the tip was charred and the length was reduced about 6mm reduction of the tip and no further u/s scan the tip was seen between the myometrium and the placenta lying in the placental bed. Talked to patient and brought back 5 days later for u/s scan to asses fetal well being and all was well, both babies are fine and the tip and visualised as said above. "
Patient Sequence No: 1, Text Type: D, B5
[21820299]
One opened package was received containing a needle. Upon removing the needle from the needle packaging protector, the cannula was noted to be burnt and blackened 14. 1cm from the proximal end most likely from a laser. Approximately 11mm of the cannula is noted to be missing. Upon examination of the stylet, the distal end excluding the bevel was noted to have an annealed appearance. Additional information from the distributor indicates the patient is aware of the situation and no further action taken clinically at this time. The remaining portion of the cannula will be removed after delivery; estimated delivery date is march 09, 2008. At this time, the appearance of the needle indicates being cut by a laser that was used during the procedure. As additional information becomes available, it will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2007-00017 |
| MDR Report Key | 919107 |
| Report Source | 01,08 |
| Date Received | 2007-09-24 |
| Date of Event | 2007-08-24 |
| Date Reported to Mfgr | 2007-09-04 |
| Date Mfgr Received | 2007-09-04 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2007-10-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TAMMY BACON |
| Manufacturer Street | 1100 WEST MORGAN STREET |
| 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 | ECHOTIP DISPOSABLE LANCET NEEDLE |
| Generic Name | ECHOTIP DISPOSABLE AMNIOCENTESIS NEEDLE |
| Product Code | HIO |
| Date Received | 2007-09-24 |
| Returned To Mfg | 2007-09-18 |
| Model Number | NA |
| Catalog Number | J-DSN-181501 |
| Lot Number | U1278151 |
| Device Expiration Date | 2008-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 892849 |
| Manufacturer | COOK UROLOGICAL |
| Manufacturer Address | SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-24 |