MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-01-28 for ENDOPATH PNEUMOPERITONEUM NEEDLE PN150 manufactured by Lacey Mfg Co..
[7762065]
H6; code 400: feedbar was adhered to the applier floor and feed bar timp was unraveled. Based upon the inquiry info received and the visual examination, it was concluded that the reported incident during surgery may have been due to dried body fluids adhering the feed bar to the applier floor. The instrument was received with excessive dried body fluids in the cartridge assembly. The feedbar was adhered to the applier floor and the feedbar tip was unraveled. No functional testing could be performed due to the unraveled feedbar. The cartridge was observed to contain 13 clips. Comments: briefly swishing the applier with saline between uses will reduce the occurrence of this incident. Each instrument is evaluated during the assembly process to ensure it functions properly. Co strives to understand each incident as it occurs in order to continuously improve products.
Patient Sequence No: 1, Text Type: N, H10
[17030838]
During a laparoscopic tubal ligation, the surgeon said the device is not long enough for obese pts. It took almost ten minutes to insufflate because the device was too short. Eventually the pn150 went through the peritoneum and insufflated successfully. There was no consequence to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218017-1997-00013 |
| MDR Report Key | 82071 |
| Report Source | 07 |
| Date Received | 1997-01-28 |
| Date of Report | 1997-01-28 |
| Date Mfgr Received | 1996-12-01 |
| Date Added to Maude | 1997-04-10 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH PNEUMOPERITONEUM NEEDLE |
| Generic Name | PNEUMOPERITONEUM NEEDLE |
| Product Code | FHP |
| Date Received | 1997-01-28 |
| Model Number | NA |
| Catalog Number | PN150 |
| Lot Number | UNK |
| ID Number | BATCH # UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 81474 |
| Manufacturer | LACEY MFG CO. |
| Manufacturer Address | 1146 BARNUM AVE. BRIDGEPORT CT 06610 US |
| Baseline Brand Name | ENDOPATH PNEUMOPERITONEUM NEEDLE |
| Baseline Generic Name | INSUFFLATION NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | PN150 |
| Baseline Device Family | ENDOPATH INSUFFLATION NEEDLE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K910855 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-28 |