FDA Adverse Event Injury Summary report: N

STIEGMANN-GOFF ENDOSCOPIC LIGATOR

MDR report key: 8488 · Received December 27, 1993

Report

Report Number: 1223688-1993-00064
Event Type: Injury
Date Received: December 27, 1993
Date of Event: October 9, 1993
Report Date: October 15, 1993
Manufacturer: SUPERIOR HEALTH CARE GROUP, INC.
Product Code: MND
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: IL, US
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

THE NURSE STATES THAT A 65 YEAR OLD FEMALE PRESENTED FOR AN ESOPHAGEAL LIGATION. THE BAND CARTRIDGE WAS ATTACHED TO THE ENDOSCOPE, THE TRIP WIRE ATTACHED AND WITH TENSION ON THE TRIP WIRE, THE ENDOSCOPE WAS INSERTED INTO THE ESOPHAGUS. WHEN THE PHYSICIAN POSITIONED ON A VAARIX, AS THE TRIP WIRE WAS PULLED, THE WIRE'S BEAD PULLED THROUGH THE CARTRIDGE CAUSING THE CARTRIDGE TO COME OFF THE ENDOSCOPE. THE CARTRIDGE WAS FOUND IN THE PT'S STOMACH AND WAS ENDOSCOPICALLY RETREIVED USING A FORCEP. THE PHYSICIAN USED ANOTHER UNIT TO SUCCESSFULLY COMPLETE THE PROCEEDURE WITHOUT FURTHER COMPLICATION.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT 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.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STIEGMANN-GOFF ENDOSCOPIC LIGATOR	LIGATOR	MND	SUPERIOR HEALTH CARE GROUP, INC.		26ICL101

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Required Intervention