MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-01 for CAPTURA HOT BIOPSY FORCEPS HDBF-2.4-230-S manufactured by Cook Endoscopy.
[137001139]
Initial reporter occupation: other healthcare professional. Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report. The device was returned with no visible signs of kinks or bends in catheter. During a functional test, the handle of the forceps was manipulated and the forceps cups would open, but would not close. The device was then placed down an olympus gif-q20 (2. 8 mm channel) endoscope. The endoscope was put in a torturous path. When the handle was manipulated, the device would open, but the cups would not close. The device was sent back to the supplier for evaluation. The supplier provided the following response: one (1) device from the reported event was returned inside of a zip type bag with proof of decontamination. The device was visually evaluated. No defects to the handle, catheter and cup assembly were noted. The device was functionally evaluated. During testing, with the devices coiled in three (3), eight (8) inch loops, it was confirmed that the device did not operate properly when the handle was manipulated. The device opened but did not close as designed. The reported event for "open and close" was confirmed. The device was disassembled to evaluate the solder connection and link wires. Both the solder connection and link wires were intact. There was insufficient overlap applied during the soldering process. The assignable cause was operator error. The device history records for packaging work order (pwo) were reviewed. Relevant defects were noted in the manufacturing and/or final quality check (fqc) checklist records. The device history record for the lot number said to be involved was reviewed. A discrepancy or anomaly was not observed with the product that was released for distribution. Investigation conclusion: the supplier provided the following: the reported issue "difficulty using device handle and cups did not open and close smoothly" was confirmed. The assignable cause was operator error. The operator(s) involved will be advised of the complaint and retrained on the procedure. The root cause for the device not being able to close was due to an incorrect solder joint. Prior to distribution, all captura hot biopsy forceps are subjected to a visual inspection and functional test to ensure proper workability. A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment. Corrective action: a review of the complaint history was conducted. The likelihood of occurrence is considered rare. Corrective action is not warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Patient Sequence No: 1, Text Type: N, H10
[137001140]
During an endoscopic procedure, the physician used a cook captura hot biopsy forceps. The user felt difficulty using the device handle and the forceps cups would not open and close smoothly. The user changed to another of the same device to complete the procedure. There was no reportable information at this time. The device was evaluated on 07-jan-2019. During a function test, the cups opened, but would not close when handle was in use. 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 | 1037905-2019-00035 |
| MDR Report Key | 8297943 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-01 |
| Date of Report | 2018-12-25 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2018-12-25 |
| Device Manufacturer Date | 2017-06-02 |
| Date Added to Maude | 2019-02-01 |
| 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 | 3 |
| Brand Name | CAPTURA HOT BIOPSY FORCEPS |
| Generic Name | KGE, FORCEPS, BIOPSY, ELECTRIC |
| Product Code | KGE |
| Date Received | 2019-02-01 |
| Returned To Mfg | 2019-01-07 |
| Catalog Number | HDBF-2.4-230-S |
| Lot Number | W4084241 |
| 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 | 2019-02-01 |