| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PRECISOR? EXL? COATED DISPOSABLE BIOPSY FORCEPS, OVAL | PRECISOR BIOPSY FORCEPS | CONMED CORPORATION | NON | 000389 | M12031503 | N | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-08-10 | 0 | 1. R |
Patient 1
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 1
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). (B)(4) UNUSED, SEALED LOT SAMPLES OF CATALOG NUMBER 000389, LOT NUMBER M12031503 WERE RECEIVED FOR EVALUATION. THE RETURNED DEVICES WERE EXAMINED IN THE LABORATORY AT CONMED CORPORATION. PER (B)(4) SAMPLING PLAN, (B)(4) 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 AND 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 (B)(4). SAMPLE DEVICES WERE SHIPPED TO (B)(4) FOR FURTHER EVALUATION. IF (B)(4) 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. LITERATURE REVIEW INCLUDED: CHARLES K F VU, MELVYN G KORMAN, IAN BEJER ANS STEPHEN DAVIS, GASTROINTESTINAL BLEEDING AFTER COLD BIOPSY. THE AMERICAN JOURNAL OF GASTROENTEROLOGY 1998; 92: 1141-1143; THE STANDARDS OF PRACTICE COMMITTEE OF THE AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY, COMPLICATIONS OF COLONOSCOPY. GASTROINTESTINAL ENDOSCOPY 2003; 57:441-445; NELSON DB, MCQUAID KR, BOND JH, LIEBERMAN DA, WEISS DG, JOHNSTON TK. PROCEDURAL SUCCESS AND COMPLICATIONS OF LARGE SCALE SCREENING COLONOSCOPY. GASTROINTESTINAL ENDOSCOPY 2002; 55:307-314; THOMAS D ATWELL, RYAN L. SMITH, ET AL. INCIDENCE OF BLEEDING AFTER 15,181 PERCUTANEOUS BIOPSIES AND THE ROLE OF ASPIRIN. AMERICAN JOURNAL OF ROENTGENOL 2010; 194(3): 784-789. 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 1
THE ACTUAL DEVICE INVOLVED IN THIS INCIDENT HAS BEEN DISCARDED BY THE END-USER FACILITY. LOT SAMPLES ARE ANTICIPATED TO BE RETURNED; HOWEVER, HAVE NOT YET BEEN RECEIVED TO DATE.WHEN THE QUALITY ENGINEERING INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. LOT SAMPLE NOT YET RETURNED TO CONMED.