MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-09 for CLASSIC BIPOLAR TUBAL FCPSSCIS5MM45CM MF985 manufactured by Aesculap Inc.
[144966266]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report. Investigation on-going.
Patient Sequence No: 1, Text Type: N, H10
[144966267]
It was reported that there was an issue with the bipolar cord and kleppinger. During a laparoscopic tubal ligation, the bipolar forceps was noted to not be working "at all". Another forceps was also attempted to be used, but it only worked intermittently. The surgeon then switched to suture ligatures instead to complete the procedure. The electric generator and pedal were working; it was unknown if the cord or the instrument malfunctioned. There was no patient harm; however, a 15-minute surgical delay occurred. Associated medwatches: 2916714-2019-00007 (this report) - not working, 2916714-2019-00009.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-2019-00007 |
| MDR Report Key | 8597258 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-03-11 |
| Date Facility Aware | 2019-03-11 |
| Date Mfgr Received | 2019-03-11 |
| Date Added to Maude | 2019-05-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSAY CHROMIAK |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal | 18034 |
| Manufacturer G1 | AESCULAP INC |
| Manufacturer Street | 3773 CORPORATE PARKWAY |
| Manufacturer City | CENTER VALLEY PA 18034 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18034 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLASSIC BIPOLAR TUBAL FCPSSCIS5MM45CM |
| Generic Name | REUSABLE INSTRUMENTS |
| Product Code | HET |
| Date Received | 2019-05-09 |
| Model Number | MF985 |
| Catalog Number | MF985 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP INC |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |