MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-01-14 for MIROCAM CAPSULE ENDOSOPE SYSTEM MC1200-G manufactured by Intromedic Co.,ltd..
[181211390]
Additional narratives regarding the event are as follows; after completing the procedure, it needs to be confirmed that the capsule has been excreted and it is stated on the page 1-17 of the user manual. However, according to the customer, they didn't confirm the excretion of the capsule out from the patient's body. In addition, they reported us that this was because of a mishandling by the staff and the capsule was removed by surgery. Also, there was no patient injury resulting from the retained device. For the above mentioned reasons, it is concluded that this is not due to the product problem.
Patient Sequence No: 1, Text Type: N, H10
[181211391]
A patient was investigated with mirocam on (b)(6) 2016 in (b)(6) hospital. The capsule was never passed to the colon, but this was not followed up due to a mishandling by the staff. Three years later the capsule was seen in the small intestine on x-ray and had to be removed by surgery. Part of the small intestine where the capsule was situated also had to be removed. Since endoscopic attempts to extract it was not successful, the patient had to go through surgery and remove a piece of the small intestine where the capsule was stuck. The capsule was removed by surgery on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007244127-2019-12001 |
| MDR Report Key | 9589434 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-11 |
| Date of Event | 2019-07-02 |
| Date Facility Aware | 2019-12-11 |
| Report Date | 2019-12-11 |
| Date Reported to Mfgr | 2019-12-11 |
| Device Manufacturer Date | 2015-11-12 |
| Date Added to Maude | 2020-01-14 |
| 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 | MR. JINYOUNG LEE |
| Manufacturer Street | SUITE 1105, 1106 41, DIGITAL-RO 31-GIL,GURO-GU |
| Manufacturer City | SEOUL, 08375 |
| Manufacturer Country | KS |
| Manufacturer Postal | 08375 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIROCAM CAPSULE ENDOSOPE SYSTEM |
| Generic Name | INGESTIBLE TELEMETRIC GASTROINTESTINAL CAPSULE IMAGING SYSTEM |
| Product Code | NEZ |
| Date Received | 2020-01-14 |
| Model Number | MC1200-G |
| Device Expiration Date | 2017-05-11 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTROMEDIC CO.,LTD. |
| Manufacturer Address | SUITE 1105, 1106 DIGITAL-RO 31 GIL, GURO-GU SEOUL, 08375 KS 08375 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-14 |