MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-04-12 for 7FR 300CM BIPOLAR HEMO PROBE BP-7300A manufactured by Conmed Corporation.
[105275207]
The used device was returned to conmed with original product packaging. Upon visual inspection, the device was observed to be missing, at the distal tip of the probe, a piece of silver epoxy. The cause of the defect was not determined during inspection; potentially this defect was a result of damage to the device. A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture. A review of this lot number, with (b)(4) manufactured, showed no other complaints for this lot product and event description. A two-year review of complaint history revealed no other similar complaints for this product family and failure mode. (b)(4). A risk analysis was performed and found this failure mode and occurrence level to be consistent and acceptable with predicted post-market risk. The instructions for use advises the user of the following. Use the lowest possible power setting on the conmed bicap electrosurgical generator capable of achieving the desired surgical effect and to use the shortest effective activation time necessary. These devices should never be used when: there is visible evidence of damage to the exterior of the device, such as cuts, punctures, nicks abrasions, unusual lumps or significant discoloration. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[105275208]
The conmed sales representative reported on behalf of the user facility that the tip of bp-7300a broke off during a procedure. Upon gathering additional information, the user facility reported the distal tip of the device became detached during cautery. The procedure was completed with surgical delays due to the retrieval of an alternate device. The patient has been discharged since this incident and did not require additional treatment or hospital stay. The broken piece was not retrieved and it was left in the patient's stomach. This report is being raised on the basis of a non implantable piece of a device detaching and left inside the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2018-00083 |
| MDR Report Key | 7425092 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-04-12 |
| Date of Report | 2018-04-12 |
| Date Mfgr Received | 2018-03-15 |
| Device Manufacturer Date | 2017-10-09 |
| Date Added to Maude | 2018-04-12 |
| 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 | MRS. MARTHA CAMACHO URRIBARRI |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243051 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 7FR 300CM BIPOLAR HEMO PROBE |
| Generic Name | BICAP MULTIELECTRODE BIPOLAR |
| Product Code | FEH |
| Date Received | 2018-04-12 |
| Returned To Mfg | 2018-03-21 |
| Catalog Number | BP-7300A |
| Lot Number | 201710091 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-12 |