MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-11-27 for ENDOPATH PNEUMOPERITONEUM NEEDLE PN120 manufactured by Lacey Mfg Co..
[32075]
During a laparoscopic tubal ligation, the surgeon inserted the veress needle. He experienced difficulty establishing pneumoperitoneum. He inserted the trocars and had the same difficulty. He could not get the insufflator to maintain pneumoperitoneum. The decision was made to convert to open to complete the device, the tubing, the veress needle, or the trocars. The surgeon thinks the problem may be due to the insufflator and it is being analyzed by the hosp. The pt was extremely heavy. The pneumo needle and the trocars are being returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
[7768251]
H6; code 100: stylet found to be within design specifications. Results of evaluation: conclusion; based upon the inquiry info received, the visual examination, and the functional test, no conclusion could be reached as to what may have caused the reported incident during surgery. The instrument was received in good physical condition and the stylet was free of occlusions. The needle was tested and functioned as designed. The stylet was found to operate smoothly and without binding. It was concluded that the needle was conforming to design specifications. The experience the customer reported could not be repeated. Each instruments 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 the products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218017-1996-00042 |
| MDR Report Key | 52220 |
| Report Source | 07 |
| Date Received | 1996-11-27 |
| Date of Report | 1996-11-26 |
| Date of Event | 1996-11-01 |
| Date Mfgr Received | 1996-11-03 |
| Date Added to Maude | 1996-12-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| 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 | 1996-11-27 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | UNK |
| ID Number | BATCH # 054-5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 52873 |
| Manufacturer | LACEY MFG CO. |
| Manufacturer Address | 1146 BARNUM AVE BRIDGEPORT CT 06610 US |
| Baseline Brand Name | ENDOPATH INSUFFLATION NEEDLE |
| Baseline Generic Name | INSUFFLATION NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | PN120 |
| Baseline ID | NA |
| 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. Required No Informationntervention | 1996-11-27 |