MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-21 for PILLCAM FGS-0353 manufactured by Given Imaging Ltd., Yoqneam.
[92664319]
To date, the incident sample has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[92664320]
According to the reporter, the customer called to inquire whether a deployment device could be used for a patency procedure. After further investigation, it was documented that the patient had a retained patency capsule in the antrum of the stomach. The retained capsule was discovered after a ct on (b)(6) 2017. Medtronic medical affairs followed-up with the customer regarding the retained capsule. The customer reported the physician was contemplating repeating the patency procedure and potentially placing the patency capsule directly in the patients small bowel. Placement would be completed by using the capsule endoscopic delivery system. The customer was concerned that the retained capsule may be punctured by the repeat procedure. It was also considered having the patient ingest the capsule and use a roth net to advance it. The patient's diagnosis was bloating and abdominal distention. Medtronic medical affairs referred the customer for use and contradictions in the user manuals. The female patient is in her (b)(6), she is receiving tpn, is diabetic, post kidney transplant, has gastroparesis, constipation, had a gastric stimulator (which was removed) and in (b)(6) 2016 was diagnosed with 3 small bowel obstructions. . The patient underwent a small bowel resection and the bowel was reportedly necrotic. The customer reported the patient was taking "a boat load of meds". It was discussed that per the patient? S history she is at risk for strictures a contraindication. Technical support spoke with medtronic medical affairs, it was suggested that perhaps the patient would simply swallow the patency capsule if a repeat procedure was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2017-05648 |
| MDR Report Key | 7049852 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-21 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-11-03 |
| Date Mfgr Received | 2017-11-03 |
| Date Added to Maude | 2017-11-21 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Street | YETSIRA 13 STREET |
| Manufacturer City | YOQNEAM 20692 |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PILLCAM |
| Generic Name | CAMERA, STILL, SURGICAL |
| Product Code | FTT |
| Date Received | 2017-11-21 |
| Model Number | FGS-0353 |
| Catalog Number | FGS-0353 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Address | YETSIRA 13 STREET YOQNEAM 20692 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-21 |