MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2012-02-15 for PRECISOR? EXL? COATED DISPOSABLE BIOPSY FORCEPS 000389 manufactured by Conmed Corporation.
[2539285]
It was reported, "there was a patient who was hospitalized for a day because of the endoscopy procedure using a conmed forceps. The operator said there was too much loss of blood because the forceps cuts the tissue instead of tearing the tissue. The operator had to pinch the wound with hemoclip. " it was also reported that the patient is stable.
Patient Sequence No: 1, Text Type: D, B5
[9716581]
The suspect device has been discarded by the end-user. Conmed is attempting to obtain additional information related to this incident. A supplemental report will be filed when the quality engineering investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[17084232]
The device in question, precisor disposable biopsy forceps, consists of a flexible sheath with grasping cups controlled by a proximal handle. These forceps are indicated for endoscopic histological sampling of various tissue sites within the gastrointestinal and bronchial tracts via the operating channel of endoscopic instruments. Dhr / lhr, device history record / lot history record, review showed that this lot was confirmed by manufacturing documentation to have been produced according to manufacturing specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness, or performance were not identified during manufacture. The device was 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). 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. Numerous attempts were made to ascertain if the patient in the reported incident had any underlying coagulopathy, or, if the patient was being treated with any medication that could block platelet aggregation, such as aspirin, plavix, warfarin, etc. These requests to the reporter of the incident went unanswered. The risk associate 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2012-00010 |
| MDR Report Key | 2453900 |
| Report Source | 07,08 |
| Date Received | 2012-02-15 |
| Date of Report | 2012-03-22 |
| Date of Event | 2011-12-13 |
| Date Mfgr Received | 2012-01-27 |
| Device Manufacturer Date | 2010-07-10 |
| Date Added to Maude | 2012-02-15 |
| 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 |
| Generic Name | PRECISOR COLD BIOPSY FORCEPS |
| Product Code | NON |
| Date Received | 2012-02-15 |
| Catalog Number | 000389 |
| Lot Number | M10060701 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization | 2012-02-15 |