MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-10-22 for PILLCAM COLON2 CAPSULE FGS-0286 manufactured by Given Imaging Ltd..
[5074722]
On (b)(6) the vumc (b)(6) performed a vce c2 procedure. After connecting the capsule with the dr3 and ingestion the capsule the image have been seen on the display of the dr3. After approx 5 minutes the dr did not receive images anymore. Capsule signal was no longer detected. The hospital changed array and dr without success and possibility was mentioned that the problem was the capsule. Four days later the patient found the capsule in her stool and the dome was separated from the body of the capsule. The patient suffered no ill effects and remains completely asymptomatic.
Patient Sequence No: 1, Text Type: D, B5
[12443639]
Upon receiving report, the customer was asked to return the capsule as soon as possible to help determine the cause of this malfunction. Unfortunately, the capsule has not been received one month after the request was made. In the interim, the following investigations were completed in the absence of the actual capsule involved: destructive test (test performed routinely to verify integrity of capsule assembly procedure including gluing process) for 23812c lot performed on (b)(4) 2013 and passed successfully. The dhr of this lot reviewed and no non conformity was found. No similar reports for the other 24 capsules from the same lot. The capsule gluing device and the capsule gluing processes validation reviewed and results showed complete conformity was found. The capsule component (dome and case) incoming inspection reviewed and meet the part specifications. The gluing coc was reviewed and conformity was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710107-2014-00194 |
| MDR Report Key | 4217041 |
| Report Source | 06 |
| Date Received | 2014-10-22 |
| Date of Report | 2014-10-23 |
| Date of Event | 2014-09-15 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-11-05 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLCAM COLON2 CAPSULE |
| Generic Name | COLON 2 CAPSULE |
| Product Code | PGD |
| Date Received | 2014-10-22 |
| Catalog Number | FGS-0286 |
| Lot Number | 23812C |
| Device Expiration Date | 2014-12-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD. |
| Manufacturer Address | HERMON BUILDING NEW INDUSTRIAL PARK, P.O.BOX 258 YOKNEAM 20692 IS 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-22 |