MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-08-25 for PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH PN120 manufactured by Ethicon Endo-surgery, Llc.
[1395702]
It was reported that during an unk procedure, the device has an obstruction in the shaft of the needle. Another device was used to complete the case. There was no adverse consequence to the pt.
Patient Sequence No: 1, Text Type: D, B5
[8578161]
(b)(4). (b)(4). Eval summary: the device was returned for analysis. The analysis results confirmed the customer's complaint. Based upon the inquiry info rec'd and visual and functional examination, the unit was found to have excessive adhesive in the stylet. The batch history records were reviewed with no anomalies noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2009-05119 |
| MDR Report Key | 1710200 |
| Report Source | 05,06,07 |
| Date Received | 2009-08-25 |
| Date of Report | 2009-07-30 |
| Date of Event | 2009-07-29 |
| Date Mfgr Received | 2009-07-30 |
| Device Manufacturer Date | 2009-03-10 |
| Date Added to Maude | 2010-07-13 |
| 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 | 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 Country | US |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH |
| Product Code | FDP |
| Date Received | 2009-08-25 |
| Returned To Mfg | 2009-07-30 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | F4NF9W |
| ID Number | BATCH # UNK |
| Device Expiration Date | 2014-03-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Address | GUAYNABO PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-25 |