MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-21 for PREC EXL JUMB ALL NDL 3.1 230 00823C manufactured by Micro-tech (nanjing) Co., Ltd..
[183312045]
The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[183312046]
The sales representative reported on behalf of the customer that the 00823c device was being used on (b)(6) 2020 during a colonoscopy procedure. When the user was taking biopsies from the patient (2 biopsies) the tissue was torn by the device. There was no hemostasis required and the procedure was completed. There was no report of injury to the patient and no medical intervention/hospitalization required. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320894-2020-00078 |
| MDR Report Key | 9738714 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-03-20 |
| Date Added to Maude | 2020-02-21 |
| 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 | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO, FL |
| Manufacturer Country | US |
| Manufacturer Phone | 3995358 |
| Manufacturer G1 | MICRO-TECH (NANJING) CO., LTD. |
| Manufacturer Street | NO. 10 GAOKE THIRD ROAD |
| Manufacturer City | NANJING, 210032 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 210032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREC EXL JUMB ALL NDL 3.1 230 |
| Generic Name | FORCEPS, BIOPSY, NON-ELECTRIC |
| Product Code | FCL |
| Date Received | 2020-02-21 |
| Catalog Number | 00823C |
| Lot Number | M191001004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO-TECH (NANJING) CO., LTD. |
| Manufacturer Address | NO. 10 GAOKE THIRD ROAD NANJING, 210032 CH 210032 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |