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 2017-10-30 for SEMI- RIGID GRASPING FORCEPS 27023FM manufactured by Karl Storz Gmbh & Co. Kg.
[91197125]
The grasping forceps were not returned to karl storz for evaluation. The hospital sent the forceps to ims a third party repair facility. Although the product still carries karl storz brand name, we cannot be certain whether that was still the original ks product.
Patient Sequence No: 1, Text Type: N, H10
[91197126]
Allegedly, during a eswl uereteral stone and cystoscopy with stent removal procedure, doctor noted that one of the jaws on grasping forceps broke off into patient's bladder. Doctor located broken piece and attempted to retrieve it, but he was unable to do so. He believes that patient should pass it on his own, since it was smaller than the stones that they were removing. Procedure was completed with no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2017-00091 |
| MDR Report Key | 6989191 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-30 |
| Date of Report | 2017-10-02 |
| Date of Event | 2017-09-13 |
| Date Mfgr Received | 2017-10-02 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2017-10-30 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG |
| Manufacturer Street | MITTELSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEMI- RIGID GRASPING FORCEPS |
| Generic Name | GRASPING FORCEPS |
| Product Code | FGC |
| Date Received | 2017-10-30 |
| Model Number | 27023FM |
| Catalog Number | 27023FM |
| Lot Number | PT02 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | MITTLESTRASSE 8 TUTTLINGEN 78503 GM 78503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-30 |