MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-19 for SPURLING RONGEUR STR 4X10MM180MM FF807R manufactured by Aesculap Ag.
[180166432]
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[180166433]
It was reported that there was an issue with spurling rongeur. According to the customer report: "during the removal (herniated disc), the middle grasping forceps in the intervertebral disc space break off. The broken-off part cannot be recovered immediately. Multiple rinsing of the intervertebral space with saline solution to remove remaining disc particles and mobilization of the metal fragment. X-ray control. The metal fragment is located in the cranial part of the intervertebral disc. Palpation of the intervertebral disc space with the nerve hook and further grasping forceps. There will be a small bleeding from the depths is detected which stops spontaneously. The tissue removed now isn't always typical for intervertebral discs. Further removal results in the rupture of a second (large) grasping forceps. The anterior fragment can now be retrieved directly. Another radiological check with a metal suction cup in the intervertebral disc space. It is shown that the suction cup has been advanced to a far retroperitoneal position, with a perforation of the anterior longitudinal ligament. The further search for the metal fragment is stopped. A final check for blood dryness is performed. An immediately performed computed tomography (ct) abdomen shows a small retroperitoneal bleeding, without arterial component. Air is shown retroperitoneally in front of the disc space l5/s1 left and right. There is also some intraperitoneal free air detectable, probably by puncture with the suction cup. Postoperatively transfer to the intensive care unit for observation. A revision surgery was necessary. Planned endoscopic recovery of the forceps fragment on (b)(6) 2020. The adverse event/malfunction is filed under (b)(4). Associated medwatch-reports: 9610612-2019-00955 ((b)(4) ff805r).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00944 |
| MDR Report Key | 9728268 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2018-11-01 |
| Date Added to Maude | 2020-02-19 |
| 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 KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPURLING RONGEUR STR 4X10MM180MM |
| Generic Name | BONE PUNCHES, RONGEURS |
| Product Code | HTX |
| Date Received | 2020-02-19 |
| Returned To Mfg | 2020-02-04 |
| Model Number | FF807R |
| Catalog Number | FF807R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-19 |