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 2018-06-06 for OPTICAL BIOPSY FORCEPS 27072A manufactured by Karl Storz Se & Co. Kg.
[110583122]
The device has not been returned, and we have been unable to obtain any further details about the event to determine a possible cause of the laceration. The picture of the instrument provided by the customer shows the jaws are intact, and the rivet/ hinge pin (approx. 1mm in size) is missing. If the pin (rivet) came off of the forceps during the procedure, this would not be likely to cause injury to the patient and the pin would most likely be passed when urinating. Per the lot code provided, the instrument had been in use for over 8 years. The most likely cause of the damage is wear of use.
Patient Sequence No: 1, Text Type: N, H10
[110583123]
Allegedly, a rivet holding the biopsy cup jaw fell out during a urological procedure in which the patient sustained a minor injury (laceration), requiring a catheter until the laceration could heal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2018-00040 |
| MDR Report Key | 7575514 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-06-06 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-05-03 |
| Date Mfgr Received | 2018-05-07 |
| Date Added to Maude | 2018-06-06 |
| 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 | 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 SE & CO. KG |
| Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTICAL BIOPSY FORCEPS |
| Generic Name | OPTICAL BIOPSY FORCEPS |
| Product Code | OCZ |
| Date Received | 2018-06-06 |
| Model Number | 27072A |
| Catalog Number | 27072A |
| Lot Number | NZ |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-06 |