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 2016-02-08 for CYTO-KIT-R CYTO-KITR manufactured by Sunnyvale.
[37713242]
(b)(4). Complaint confirmed. The sponge has come detached from the suture. Visual inspection indicated a slice through a portion of the sponge. Slice 10mm deep and 20. 7mm wide, cutting through 17 struts across the sponge. A small piece of sponge is missing from the top of the slice suggesting that the suture tore free from the sponge. The sponge meets manufacturing specifications. The depth of the slice meets expectations for how deep the suture must be placed for the sponge. Initial inspection meets all manufacturing specifications. Root cause analysis in progress.
Patient Sequence No: 1, Text Type: N, H10
[37713243]
It was reported that the cytosponge during the procedure on (b)(6) 2016 the suture broke causing the sponge to detach from the suture. The physician confirmed that the sponge was retrieved immediately during endoscopy. The sponge was retrieved with no harm to patient. The device broke at the upper esophageal sphincter. The patient reported no symptoms or erosions.
Patient Sequence No: 1, Text Type: D, B5
[39546917]
The investigation shows that there is no evidence suggesting the sponge device was not manufactured correctly.
Patient Sequence No: 1, Text Type: N, H10
[42208649]
Patient Sequence No: 1, Text Type: N, H10
[42278719]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[49156544]
(b)(4). Evaluation summary: investigations led an evaluation on one cyto-kitr that was returned for evaluation. The customer reporter that the suture detached from the cytosponge. Inspection led by engineering verified that there was no evidence to indicate that the sponge was not manufactured correctly. A review of the device history record for the provided lot/serial number was completed and acceptance criteria for entries potentially pertinent to the customer's report were within specified limits at the time of release.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004904811-2016-00002 |
| MDR Report Key | 5418385 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-08 |
| Date of Report | 2016-02-19 |
| Date of Event | 2016-01-11 |
| Date Mfgr Received | 2016-05-05 |
| Date Added to Maude | 2016-02-08 |
| 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 | 540 OAKMEAD PARKWAY |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | PATH-TEC |
| Manufacturer Street | 5700 OLD BRIM ROAD |
| Manufacturer City | MIDLAND GA 31820 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 31820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CYTO-KIT-R |
| Generic Name | ESOPHAGOSCOPE |
| Product Code | EOX |
| Date Received | 2016-02-08 |
| Returned To Mfg | 2016-01-25 |
| Model Number | CYTO-KITR |
| Catalog Number | CYTO-KITR |
| Lot Number | F2500202X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNNYVALE |
| Manufacturer Address | 540 OAKMEAD PARKWAY SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-02-08 |