MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-20 for CAPTURA MINI BIOPSY FORCEPS W/O SPIKE DBF-1.8-160-S manufactured by Cook Endoscopy.
[114853829]
Suspect medical device: common name- forceps, biopsy, non-electric, product code- pts. Investigation evaluation: our laboratory evaluation of the product said to be involved could not confirm the report as it was described. While we cannot confirm that the cups will not close, we can confirm that upon opening the forceps cups, one (1) cup opens while the other one does not. When the handle was manipulated, one (1) of the forceps cups will open, while the other stays in the closed position. When the device is in the closed position, one (1) of the flanges of the forceps cups protrudes through the forceps cup housing. When the handle of the forceps is resting, the forceps cups slightly open on their own, but once pressure is applied to the device, the forceps cups will close. The device was placed down an olympus bf-160 endoscope and will open and close while the endoscope is in a torqued position. The device will be sent back to the supplier for evaluation. The product was returned to the approved supplier for evaluation and the investigation is on-going. Once additional information has been received a follow-up emdr report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[114853830]
During a biopsy procedure, the physician used a cook captura mini biopsy forceps w/o spike. The biopsy was performed with the captura device in the stomach. However, because one of the forceps cups did not close, the biopsied specimen was not inside the cups when the device was removed through the endoscope. Another device, likely to be the same product from another lot, was used instead to complete the procedure. A section of the device did not remain inside the patient? S body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2018-00325 |
| MDR Report Key | 7706106 |
| Date Received | 2018-07-20 |
| Date of Report | 2018-06-26 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2018-02-15 |
| Date Added to Maude | 2018-07-20 |
| 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 | MS. SCOTTIE FARIOLE |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Manufacturer G1 | COOK ENDOSCOPY |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27105 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPTURA MINI BIOPSY FORCEPS W/O SPIKE |
| Product Code | FBK |
| Date Received | 2018-07-20 |
| Returned To Mfg | 2018-07-05 |
| Catalog Number | DBF-1.8-160-S |
| Lot Number | W4034929 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK ENDOSCOPY |
| Manufacturer Address | 4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-20 |