MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-06 for ATRAUMATIC BOWEL GRASPER ERAGON 8394.4946 manufactured by Richard Wolf Gmbh.
[139338249]
(b)(4) considers this case open. The manufacturer will be contacted in an effort to collect missing information.
Patient Sequence No: 1, Text Type: N, H10
[139338250]
On (b)(6) 2019, the user facility reported the following to (b)(4)): the grasper was being used during case, the case was completed and the incision was closed. Upon cleaning the grasper, it was discovered that the tip had broken off. They had to open the patient back up and look for the tip. The tip was found, removed, and the patient was closed up again. Will the device be returned? Yes. Was the device being used during a procedure when the issue occurred? Yes. Specifically, was the device being used on a patient when the issue occurred? Yes. Was there any injury or illness to patient or other personnel due to issue? No. Did the issue cause a delay in the procedure being performed that put the patient at risk? No. Was there a similar back-up device available for use? Yes. Was the scheduled procedure completed? Yes. How was the patient anesthetized? General.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2019-00010 |
| MDR Report Key | 8396931 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-06 |
| Date of Report | 2019-02-06 |
| Date of Event | 2019-02-06 |
| Date Facility Aware | 2019-02-06 |
| Report Date | 2019-06-07 |
| Date Reported to FDA | 2019-06-07 |
| Date Reported to Mfgr | 2019-06-07 |
| Date Mfgr Received | 2019-05-08 |
| Device Manufacturer Date | 2009-12-02 |
| Date Added to Maude | 2019-03-06 |
| 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 | MR. OLIVER EHRLICH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATRAUMATIC BOWEL GRASPER ERAGON |
| Generic Name | ATRAUMATIC BOWEL GRASPER ERAGON |
| Product Code | HET |
| Date Received | 2019-03-06 |
| Returned To Mfg | 2019-02-14 |
| Model Number | 8394.4946 |
| Catalog Number | 8394.4946 |
| Lot Number | 1081802 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STREET 32 KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-06 |