CAPSOCAM SV-3
Report
- Report Number
- 3008062894-2025-00002
- Event Type
- Injury
- Date Received
- January 24, 2025
- Date of Event
- December 27, 2024
- Report Date
- May 12, 2025
- Manufacturer
- CAPSOVISION, INC
- Product Code
- NEZ
- PMA / PMN Number
- K242643
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
12/27/2024 - THE DOWNLOAD CENTER RECEIVED A CAPSULE WITH A CRACK IN THE WINDOW OF THE CAPSULE. WE WERE ABLE TO EXTRACT THE DATA SUCCESSFULLY. THE VIDEO LOOKED NORMAL AND IT WAS UPLOADED TO CAPSOCLOUD. WE NOTIFIED THE CUSTOMER THAT THE CAPSULE WAS RECEIVED WITH A CRACK AND SENT FRM-0089C TO REQUEST ADDITIONAL INFORMATION INCLUDING PATIENT CONDITION. ON (B)(6) 2025 - WE WERE NOTIFIED THE CAPSULE WAS REMOVED VIA EGD. WE SENT THE FRM-0089C ON 12/27/2024 AND FOLLOWED UP ON 12/31/2024 & 1/21/2025 WITHOUT ANY RESPONSE, THEREFORE THIS COMPLAINT WILL BE REPORTED AND CLOSED. HOWEVER, IT WILL BE REOPENED IF AND WHEN ADDITIONAL INFORMATION IS RECEIVED. SINCE THE POSSIBILITY OF THE CAPSULE COMING APART IS A KNOWN RISK, WE HAVE TESTED THE CAPSULES FOR LONG TERM SUBMERSION TO ANALYZE MECHANICAL INTEGRITY OF THE BOND BETWEEN THE WINDOW AND CAP OF THE CAPSULE WITH RESULTS WHERE THE ADHESIVE JOINT SHOWED MINIMAL EXPANSION DURING THE 6-MONTH TEST IN PH 2 AND PH 8 SOLUTIONS. THE CAP AND WINDOW REMAINED BONDED AND NO CRACKS WERE OBSERVED. ALSO, TO RESEARCH IF IN CASE THE CAPSULE OPENS HOW WOULD IT AFFECT THE PATIENT'S BODY, WE PERFORMED THE CYTOTOXICITY TEST WITH A LEAKING CRACKED CAPSULE. THE RESULTS SHOWED THAT A CAPSULE LODGED ANYWHERE IN THE GI TRACT WOULD BE FLUSHED WITH FRESH FLUIDS AT A RATE THAT WOULD RESULT IN HIGHER DILUTIONS THAN 1:2 AND THUS NO CYTOTOXICITY. IN ADDITION, WE TESTED THE SHARPNESS OF THE OBJECTS INSIDE THE CAPSULE TO ASSESS HOW IT WOULD IMPACT A PATIENT IF IT OPENED UP AND ALL TESTS PASSED THE SHARPNESS TEST ACCORDING TO ASTM F963-23 STANDARDS, WITH NO CUTS EXCEEDING THE 13MM ACCEPTANCE CRITERIA.
12/27/2024 - THE DOWNLOAD CENTER RECEIVED A CAPSULE WITH A CRACK IN THE WINDOW OF THE CAPSULE. WE WERE ABLE TO EXTRACT THE DATA SUCCESSFULLY. THE VIDEO LOOKED NORMAL AND IT WAS UPLOADED TO CAPSOCLOUD. WE NOTIFIED THE CUSTOMER THAT THE CAPSULE WAS RECEIVED WITH A CRACK AND SENT FRM-0089C TO REQUEST ADDITIONAL INFORMATION INCLUDING PATIENT CONDITION. 1/6/2025 - WE WERE NOTIFIED THE CAPSULE WAS REMOVED VIA EGD. WE SENT THE FRM-0089C ON 12/27/2024 AND FOLLOWED UP ON 12/31/2024 & 1/21/2025 WITHOUT ANY RESPONSE, THEREFORE THIS COMPLAINT WILL BE REPORTED AND CLOSED. HOWEVER, IT WILL BE REOPENED IF AND WHEN ADDITIONAL INFORMATION IS RECEIVED. SINCE THE POSSIBILITY OF THE CAPSULE COMING APART IS A KNOWN RISK, WE HAVE TESTED THE CAPSULES FOR LONG TERM SUBMERSION TO ANALYZE MECHANICAL INTEGRITY OF THE BOND BETWEEN THE WINDOW AND CAP OF THE CAPSULE WITH RESULTS WHERE THE ADHESIVE JOINT SHOWED MINIMAL EXPANSION DURING THE 6-MONTH TEST IN PH 2 AND PH 8 SOLUTIONS. THE CAP AND WINDOW REMAINED BONDED AND NO CRACKS WERE OBSERVED. ALSO, TO RESEARCH IF IN CASE THE CAPSULE OPENS HOW WOULD IT AFFECT THE PATIENT'S BODY, WE PERFORMED THE CYTOTOXICITY TEST WITH A LEAKING CRACKED CAPSULE. THE RESULTS SHOWED THAT A CAPSULE LODGED ANYWHERE IN THE GI TRACT WOULD BE FLUSHED WITH FRESH FLUIDS AT A RATE THAT WOULD RESULT IN HIGHER DILUTIONS THAN 1:2 AND THUS NO CYTOTOXICITY. IN ADDITION, WE TESTED THE SHARPNESS OF THE OBJECTS INSIDE THE CAPSULE TO ASSESS HOW IT WOULD IMPACT A PATIENT IF IT OPENED UP AND ALL TESTS PASSED THE SHARPNESS TEST ACCORDING TO ASTM F963-23 STANDARDS, WITH NO CUTS EXCEEDING THE 13MM ACCEPTANCE CRITERIA. ADDITIONAL INFORMATION RECEIVED AFTER THE CLOSURE OF THE COMPLAINT. 4/21/2025 - FRM-0089C CAPSULE INCIDENT QUESTIONNAIRE WAS RECEIVED INDICATING THE PATIENT RETAINED THE CAPSULE FOR OVER 72HRS AND HAD "DELAYED GASTRIC MOTILITY, RESULTED IN EGD TO EXTRACT THE PILL CAMERA FOR THE GASTRIC BEZOAR", THE CUSTOMER WAS NOT AWARE OF ANY PRE-EXISTING CONDITIONS THAT COULD HAVE LED TO THE RETENTION AND SUBSEQUENT EXTRACTION.
12/27/2024 - THE DOWNLOAD CENTER RECEIVED A CAPSULE WITH A CRACK IN THE WINDOW OF THE CAPSULE. WE WERE ABLE TO EXTRACT THE DATA SUCCESSFULLY. THE VIDEO LOOKED NORMAL AND IT WAS UPLOADED TO CAPSOCLOUD. WE NOTIFIED THE CUSTOMER THAT THE CAPSULE WAS RECEIVED WITH A CRACK AND SENT FRM-0089C TO REQUEST ADDITIONAL INFORMATION INCLUDING PATIENT CONDITION. ON (B)(6) 2025 - WE WERE NOTIFIED THE CAPSULE WAS REMOVED VIA EGD. WE SENT THE FRM-0089C ON 12/27/2024 AND FOLLOWED UP ON 12/31/2024 & 1/21/2025 WITHOUT ANY RESPONSE, THEREFORE THIS COMPLAINT WILL BE REPORTED AND CLOSED. HOWEVER, IT WILL BE REOPENED IF AND WHEN ADDITIONAL INFORMATION IS RECEIVED. SINCE THE POSSIBILITY OF THE CAPSULE COMING APART IS A KNOWN RISK, WE HAVE TESTED THE CAPSULES FOR LONG TERM SUBMERSION TO ANALYZE MECHANICAL INTEGRITY OF THE BOND BETWEEN THE WINDOW AND CAP OF THE CAPSULE WITH RESULTS WHERE THE ADHESIVE JOINT SHOWED MINIMAL EXPANSION DURING THE 6-MONTH TEST IN PH 2 AND PH 8 SOLUTIONS. THE CAP AND WINDOW REMAINED BONDED AND NO CRACKS WERE OBSERVED. ALSO, TO RESEARCH IF IN CASE THE CAPSULE OPENS HOW WOULD IT AFFECT THE PATIENT'S BODY, WE PERFORMED THE CYTOTOXICITY TEST WITH A LEAKING CRACKED CAPSULE. THE RESULTS SHOWED THAT A CAPSULE LODGED ANYWHERE IN THE GI TRACT WOULD BE FLUSHED WITH FRESH FLUIDS AT A RATE THAT WOULD RESULT IN HIGHER DILUTIONS THAN 1:2 AND THUS NO CYTOTOXICITY. IN ADDITION, WE TESTED THE SHARPNESS OF THE OBJECTS INSIDE THE CAPSULE TO ASSESS HOW IT WOULD IMPACT A PATIENT IF IT OPENED UP AND ALL TESTS PASSED THE SHARPNESS TEST ACCORDING TO ASTM F963-23 STANDARDS, WITH NO CUTS EXCEEDING THE 13MM ACCEPTANCE CRITERIA.
(B)(6) 2024 - THE DOWNLOAD CENTER RECEIVED A CAPSULE WITH A CRACK IN THE WINDOW OF THE CAPSULE. WE WERE ABLE TO EXTRACT THE DATA SUCCESSFULLY. THE VIDEO LOOKED NORMAL AND IT WAS UPLOADED TO CAPSOCLOUD. WE NOTIFIED THE CUSTOMER THAT THE CAPSULE WAS RECEIVED WITH A CRACK AND SENT FRM-0089C TO REQUEST ADDITIONAL INFORMATION INCLUDING PATIENT CONDITION. (B)(6) 2025 - WE WERE NOTIFIED THE CAPSULE WAS REMOVED VIA EGD. WE SENT THE FRM-0089C ON 12/27/2024 AND FOLLOWED UP ON 12/31/2024 & 1/21/2025 WITHOUT ANY RESPONSE, THEREFORE THIS COMPLAINT WILL BE REPORTED AND CLOSED. HOWEVER, IT WILL BE REOPENED IF AND WHEN ADDITIONAL INFORMATION IS RECEIVED. SINCE THE POSSIBILITY OF THE CAPSULE COMING APART IS A KNOWN RISK, WE HAVE TESTED THE CAPSULES FOR LONG TERM SUBMERSION TO ANALYZE MECHANICAL INTEGRITY OF THE BOND BETWEEN THE WINDOW AND CAP OF THE CAPSULE WITH RESULTS WHERE THE ADHESIVE JOINT SHOWED MINIMAL EXPANSION DURING THE 6-MONTH TEST IN PH 2 AND PH 8 SOLUTIONS. THE CAP AND WINDOW REMAINED BONDED AND NO CRACKS WERE OBSERVED. ALSO, TO RESEARCH IF IN CASE THE CAPSULE OPENS HOW WOULD IT AFFECT THE PATIENT'S BODY, WE PERFORMED THE CYTOTOXICITY TEST WITH A LEAKING CRACKED CAPSULE. THE RESULTS SHOWED THAT A CAPSULE LODGED ANYWHERE IN THE GI TRACT WOULD BE FLUSHED WITH FRESH FLUIDS AT A RATE THAT WOULD RESULT IN HIGHER DILUTIONS THAN 1:2 AND THUS NO CYTOTOXICITY. IN ADDITION, WE TESTED THE SHARPNESS OF THE OBJECTS INSIDE THE CAPSULE TO ASSESS HOW IT WOULD IMPACT A PATIENT IF IT OPENED UP AND ALL TESTS PASSED THE SHARPNESS TEST ACCORDING TO ASTM F963-23 STANDARDS, WITH NO CUTS EXCEEDING THE 13MM ACCEPTANCE CRITERIA. ADDITIONAL INFORMATION RECEIVED AFTER THE CLOSURE OF THE COMPLAINT. 4/21/2025 - FRM-0089C CAPSULE INCIDENT QUESTIONNAIRE WAS RECEIVED INDICATING THE PATIENT RETAINED THE CAPSULE FOR OVER 72HRS AND HAD "DELAYED GASTRIC MOTILITY, RESULTED IN EGD TO EXTRACT THE PILL CAMERA FOR THE GASTRIC BEZOAR", THE CUSTOMER WAS NOT AWARE OF ANY PRE-EXISTING CONDITIONS THAT COULD HAVE LED TO THE RETENTION AND SUBSEQUENT EXTRACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1057516 | CAPSOCAM SV-3 | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE | NEZ | CAPSOVISION, INC | SV-3 | 01-24-0151 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Required Intervention |