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 2018-09-27 for DISPOSABLE HOT BIOPSY FORCEPS SD-230U-20 manufactured by Olympus Medical Systems Corp..
[121991231]
The device has not returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. Despite several followup attempts by phone and in writing, there is no further information on the type of procedure, the tissue perforated, what role the reported failure to activate played in the perforation, whether the device was inspected before use, the additional surgical intervention, the patient? S current condition, or the concomitant devices involved. As preventive measures, the device instruction manual contains several warning and caution statements for avoiding patient perforation:? Do not insert the instrument into the endoscope unless you have a clear endoscopic field of view. If you cannot see the distal end of the insertion portion in the endoscopic field of view, do not use it. This could cause patient injury, such as perforation? ? Do not force the distal end of the insertion portion against body cavity tissue. This could cause patient injury, such as perforation? ? Do not angulate the bending section of the endoscope abruptly while the distal end of the insertion portion is extended from the distal end of the endoscope. This could cause patient injury, such as perforation? ? Always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures. Excessive output levels or times may result in patient injury, such as perforation? ? Do not activate output when the distal end of the endoscope is too close to or in contact with the metal portion at the distal end of the forceps insertion portion. This could cause patient injury, such as perforation? And? Aspirate fluids, such as mucus, that adhere to the distal end of the insertion portion and body cavity tissues. If output is activated with these fluids left attached, if could cause patient injury, such as perforation?. The instruction manual also contains directions for pre-procedure inspection of the device, including visual and tactile inspection, and verification of mechanical operation.
Patient Sequence No: 1, Text Type: N, H10
[121991232]
Olympus was informed that during an unknown procedure, the physician initially thought the device was not activating on the intended polyp tissue. The clinician later noticed that he had perforated past the mucosa and he was able to see the intestines. The patient had to be sent out for surgical intervention. The patient? S current condition is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00581 |
| MDR Report Key | 7915548 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-27 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-08-17 |
| Date Mfgr Received | 2018-11-30 |
| Date Added to Maude | 2018-09-27 |
| 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. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE HOT BIOPSY FORCEPS |
| Generic Name | DISPOSABLE HOT BIOPSY FORCEPS |
| Product Code | KGE |
| Date Received | 2018-09-27 |
| Model Number | SD-230U-20 |
| Catalog Number | SD-230U-20 |
| Lot Number | V7112 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-27 |