MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-12-01 for INSUFFLATION NEEDLE PN120 manufactured by Ethicon Endo-surgery, Llc..
[19188889]
It was reported that during a diagnostic laparoscopic procedure, they could not put water into the needle. It was blocked. A new one was used to complete the procedure. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[19331148]
(b)(4). Based upon the visual and functional examination, it was concluded that the needle stylet was blocked with excess adhesive. The device was received with dried body fluids on it. Analysis confirms the customers complaint. The batch record was reviewed and no anomalies were noted during the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2010-06776 |
| MDR Report Key | 1911962 |
| Report Source | 05,07 |
| Date Received | 2010-12-01 |
| Date of Report | 2010-11-09 |
| Date of Event | 2010-10-28 |
| Date Mfgr Received | 2010-11-08 |
| Date Added to Maude | 2010-12-02 |
| 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 | 0 |
| Manufacturer Contact | KATHY RICE |
| Manufacturer Street | 4545 CREEK RD |
| Manufacturer City | CINCINNATI OH 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO PR 00969 |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSUFFLATION NEEDLE |
| Generic Name | NSUFFLATION NEEDLE - 120MM LENGTH |
| Product Code | FDP |
| Date Received | 2010-12-01 |
| Returned To Mfg | 2010-11-30 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | G4TL6Y |
| ID Number | BATCH # UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Address | 475 CALLE C GUAYNABO PR 00969 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-01 |