CAPSOCAM SV-3
Report
- Report Number
- 3008062894-2024-00036
- Event Type
- Injury
- Date Received
- July 11, 2024
- Date of Event
- February 2, 2023
- Report Date
- July 10, 2024
- Manufacturer
- CAPSOVISION, INC
- Product Code
- NEZ
- PMA / PMN Number
- K192662
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
"2/2/2023 - WE WERE CONTACTED BY A CUSTOMER WHO STATES HE WAS USING THE CAPSOCAM SYSTEM AND ONE OF HIS PATIENTS INGESTED A CAPSULE WHICH HAS BEEN STUCK FOR THE PAST 2 MONTHS, PRESUMABLY BECUASE OF A STRICTURE. FRM-0089 WAS SENT TO THE CUSTOMER TO GATHER MORE INFORMATION. 02/21/2023 - WE GAVE THE CUSTOMER THE CONTACT OF DR. (B)(6) TO SOLVE QUESTIONS AND REQUESTED THE FRM-89 AGAIN. AS WE REACHED OUT ON 2/27, 3/13. 3/21, 4/19, 5/9, 5/23, 5/26 AND 6/1 WITHOUT RESPONSE, THIS COMPLAINT WILL BE CLOSED AND WILL BE REOPENED IF MORE INFORMATION COMES IN."
"2/2/2023 - WE WERE CONTACTED BY A CUSTOMER WHO STATES HE WAS USING THE CAPSOCAM SYSTEM AND ONE OF HIS PATIENTS INGESTED A CAPSULE WHICH HAS BEEN STUCK FOR THE PAST 2 MONTHS, PRESUMABLY BECUASE OF A STRICTURE. FRM-0089 WAS SENT TO THE CUSTOMER TO GATHER MORE INFORMATION. 02/21/2023 - WE GAVE THE CUSTOMER THE CONTACT OF DR. (B)(6) TO SOLVE QUESTIONS AND REQUESTED THE FRM-89 AGAIN. AS WE REACHED OUT ON 2/27, 3/13. 3/21, 4/19, 5/9, 5/23, 5/26 AND 6/1 WITHOUT RESPONSE, THIS COMPLAINT WILL BE CLOSED AND WILL BE REOPENED IF MORE INFORMATION COMES IN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2385090 | CAPSOCAM SV-3 | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE | NEZ | CAPSOVISION, INC | SV-3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |