MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-14 for OLYMPUS LOOP CUTTER FS-5U-1 manufactured by Olympus Medical Systems Corp..
[144994274]
The cause of the reported event cannot be determined at this time. The customer stated the device is available for return however, the device has not been received at the time of this report. The fs-5u-1 instruction manual states,? Before each case, prepare and inspect the instrument as instructed below. Inspect other equipment to be used with the instrument as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use the instrument; contact olympus. Damage or irregularity may compromise patient or user safety, such as punctures, hemorrhages or mucous membrane damage and may result in more severe equipment damage.? If additional information becomes available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[144994275]
The manufacturer was informed that during a therapeutic total colonoscopy procedure, the polyloop and loop cutter became stuck in the patient causing a rectum laceration. The doctor attempted to use the loop cutter to cut the loop; however, it became entangle with the patient? S mucous membrane. The intended procedure was completed. This is 1 of 2 complaints.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00838 |
| MDR Report Key | 8608330 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-14 |
| Date of Report | 2019-08-18 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-07-30 |
| Date Added to Maude | 2019-05-14 |
| 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 | 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 | OLYMPUS LOOP CUTTER |
| Generic Name | LOOP CUTTER |
| Product Code | PTS |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2019-07-17 |
| Model Number | FS-5U-1 |
| Lot Number | K8Z13-9349 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-14 |