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 2020-03-31 for GRASPING FORCEPS FG-53SX-1 manufactured by Olympus Medical Systems Corp..
[185943326]
The suspect device was returned to olympus and evaluated. Based on the evaluation and findings, olympus confirmed the reported complaint of "failed to open and close. " although a definitive root cause could not be established, it was noted that heavy corrosion was present on the jaw, which may have compromised the characteristic of the metal, causing it to break and resulting in the users' experience. Per the instruction manual under the warning section, page 27 states: "1. Reprocess the instrument immediately after use, first by immersing it in a neutral, low-foaming, medical grade detergent solution, then following the cleaning and sterilization procedures given in this chapter. Failure to reprocess the instrument immediately after use, or using other than a medical-grade detergent may cause corrosion at the metal parts like the grasping jaws. This could impair the operation of the instrument or cause a part of it to break and/or fall off inside the patient". 2. Do not grasp objects or tissue with excessive force. The grasping jaws may become damaged and could fall off inside the patient. Continuously monitor the endoscopic image during the procedure, and make sure that the instrument appears and operates properly. If a part of the instrument falls off inside the patient, stop using it immediately. Use a spare instrument to retrieve the part".
Patient Sequence No: 1, Text Type: N, H10
[185943327]
Olympus was informed that the sharp tooth grasping forceps jaws failed to open and close properly after 3 to 4 uses during the procedure. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2020-01903 |
| MDR Report Key | 9903441 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRASPING FORCEPS |
| Generic Name | GRASPING FORCEPS |
| Product Code | PTS |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-02-26 |
| Model Number | FG-53SX-1 |
| Lot Number | K9X11-8663 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |