FDA Adverse Event Malfunction Summary report: N

KLI LUBRICANT GREASE USED W/NEZHAT SUCTION IRRIGATION PROBES

MDR report key: 4381 · Received January 21, 1993

Report

Report Number: 4381
Event Type: Malfunction
Date Received: January 21, 1993
Date of Event: July 9, 1992
Report Date: July 25, 1992
Manufacturer: CABOT CORPORATION
Product Code: EIB
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

ON 7/9/92, THE RISK MANAGEMENT OFFICE HAS BEEN NOTIFIED BY THE FDA OF AN IMMEDIATE PRODUCT RECALL REGARDING KLI LIBRICANT USED ON THE NEZHAT SUCTION IRRIGATOR PROBES. THE APPROPRIATE REPLACEMENT SPRAY WHICH CAN BE UTILIZED IS MILTEX SPRAY LUBEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	KLI LUBRICANT GREASE USED W/NEZHAT SUCTION IRRIGATION PROBES		EIB	CABOT CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other