MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-25 for 120MM INSUFF NEEDLE 900-200 manufactured by Coopersurgical, Inc..
[73794325]
Coopersurgical, inc. Is currently investigating the reported complaint condition. It is anticipated that the device involved in the complaint shall be returned by the customer under (b)(4). Once the investigation is complete, a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73794326]
(b)(4). "increasing problem, used to be two or three bad one's per year,then had several in past two months, now three in one case. Some of our surgeons perform an occlusion test on the field prior to utilizing the veress needle. The goal of the occlusion test is to ensure that a high pressure alarm is triggered on the insufflator prior to using the needle. In each case, sometimes following the use of several needles, they were able to trigger the high pressure alarm ruling out an issue with the insufflator. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2017-00025 |
| MDR Report Key | 6518092 |
| Date Received | 2017-04-25 |
| Date of Report | 2017-07-31 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-03-29 |
| Device Manufacturer Date | 2016-10-16 |
| Date Added to Maude | 2017-04-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 120MM INSUFF NEEDLE |
| Generic Name | 120MM INSUFF NEEDLE |
| Product Code | FHO |
| Date Received | 2017-04-25 |
| Model Number | 900-200 |
| Catalog Number | 900-200 |
| Lot Number | 213729 |
| Device Expiration Date | 2020-01-03 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-25 |