[152390]
On december 21, 1999, importer rec'd a medwatch report from a 3rd party biomedical investigator, regarding an event with a jarit medical device at a user facility. Jarit surgical instruments (j jamner surgical instruments) is an initial distributor of medical devices. As such, importer has completed section f of form 3500a, a copy of which is enclosed along with the medwatch report. In accordance with fda procedures, copies of both the user facility's report and our form 3500a have been forwarded to the mfr of this device, tontarra medizintchnik gmbh, kantstr. 33, 78573 wurmlingen, germany. The user facility contact, was reached and stated that there was no pt injury. She reported that the blade of an endoscopic scissors fell into the pt and initial attempts to retrieve it were unsuccessful. Subsequently, the hosp decided not to try to locate the piece, no x-rays were taken, and no further procedure or surgery was implemented. The device involved has not been released from the hosp. Once rec'd it will be forwarded to the mfr for their eval. The mfr will complete the applicable sections of the form 3500a and forward all copies to fda.
Patient Sequence No: 1, Text Type: D, B5