MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-08-22 for PRECISOR? EXL? COATED DISPOSABLE BIOPSY FORCEPS, OVAL 000389 manufactured by Conmed Corporation.
[2929147]
It was reported to conmed that, "when taking biopsies the clinical staff have found that the forceps are causing bruising prior to taking the biopsy and causing tearing of the mucosa". It was also reported that, "surgical intervention of clipping was required at the biopsy site. "
Patient Sequence No: 1, Text Type: D, B5
[10012510]
I apologize for the late filing of this report. This complaint was received july 18, 2012 and was initially reported to the fda on medwatch report number 1320894-2012-00051 for a different lot number. Initial evaluation of the complaint viewed this as a single incident. On further review it was realized that the complaint from this facility for this failure mode occurred for two biopsy forceps (same catalog number) of two distinct lot numbers. This report is being filed for the second lot number involved with the same failure mode. The actual device involved in this incident has been discarded by the end-user facility. The complaint device is not available for evaluation; therefore, the condition of the device could not be assessed (i. E. , any device damage, malfunction, or defects). Ten (10) unused, sealed lot samples of catalog number 000389, lot number m120322001 were received for evaluation. The returned devices were examined in the laboratory at conmed corporation. Per (b)(4) sampling plan, level 1. 0, two (2) randomly selected devices were visually checked during the examination. No physical damage such as scratches, kinks were observed during the examination. Biopsy forceps jaws were properly opened & closed during the investigation and no discrepancies were observed with the inspected devices. No jaw misalignment issue was observed during the examination. Possible cause could be misaligned or dull jaw assembly; however, no root cause can be determined without the examination of the actual device utilized in the incident. Product is manufactured at micro-tech, (b)(4). Sample devices were shipped to micro-tech for further evaluation. If micro-tech investigation reveals any findings not mentioned in this report a supplemental medwatch will be filed to update the incident. Review of the scientific literature has shown the rarity of clinically significant hemorrhage, resulting from gastrointestinal cold biopsy; nevertheless, gastrointestinal hemorrhage is a known potential complication of the procedure. Hemorrhage may occur immediately after biopsy procedure or can be delayed for as many as 29 days after the procedure. There may be an increased risk of hemorrhage either because of medication use or the patient exhibiting an underlying coagulopathy. The risk associated with this complaint is mitigated in the ifu, information for use, provided with the device that states, "adverse reactions associated with the use of biopsy forceps include acute and delayed hemorrhage, bowel perforation, localized or systemic infections and other risks associated with the methods and medications utilized in surgical procedures". The ifu also warns that, "hemorrhage from inadvertent damage of organs and vessels and taking multiple biopsies may result from the use of this device. Therefore, the physician is advised to pay close attention to the general principles of proper hemostasis during the procedure, as well as to inspect the biopsy area prior to conclusion of the procedure. " the complaint investigation has not identified a manufacturing defect; therefore, corrective action is not warranted at this time. Bleeding complications are a rare occurring, yet inherent complication of cold biopsy procedures. Conmed is considering this complaint closed. The following medwatch reports are related: 1320894-2012-00051 and 1320894-2012-00058.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2012-00058 |
| MDR Report Key | 2710220 |
| Report Source | 06,07 |
| Date Received | 2012-08-22 |
| Date of Report | 2012-08-22 |
| Date Mfgr Received | 2012-07-18 |
| Date Added to Maude | 2012-08-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. STEPHEN CASANOVA |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 3156243463 |
| Manufacturer G1 | MICROTECH |
| Manufacturer Street | BIO-MEDICINE PARK NATIONAL NEW &HIGHTECHDEV.ZONE |
| Manufacturer City | NAN JING, CHINA 210061 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 210061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECISOR? EXL? COATED DISPOSABLE BIOPSY FORCEPS, OVAL |
| Generic Name | PRECISOR BIOPSY FORCEPS |
| Product Code | NON |
| Date Received | 2012-08-22 |
| Catalog Number | 000389 |
| Lot Number | M120322001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502599 US 13502 5994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-08-22 |