FDA Adverse Event Injury Summary report: N

ERBE USA INC.

MDR report key: 5220551 · Received November 6, 2015

Report

Report Number
MW5057812
Event Type
Injury
Date Received
November 6, 2015
Date of Event
October 27, 2015
Report Date
November 6, 2015
Manufacturer
ERBE USA INC.
Product Code
GEI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PER THE OPERATIVE REPORT, ON (B)(6) 2015, PATIENT UNDERWENT ERCP, SPHINCTEROTOMY AND STONE REMOVAL. OLYMPUS VIDEO ERCP SCOPE WAS INTRODUCED IN THE ESOPHAGUS. THE COMMON BILE DUCT WAS SELECTIVELY CANNULATED AND INJECTED. IT WAS DILATED WITH MULTIPLE FILLING DEFECTS CONSISTENT WITH COMMON BILE DUCT STONES. GALLBLADDER WAS NOT VISUALIZED. A 3/4 OF 1-CM SPHINCTEROTOMY WAS PERFORMED USING A 12-MM BALLOON, MULTIPLE PASSES RESULTED IN MULTIPLE STONES BEING REMOVED. A FINAL CHOLANGIOGRAM SHOWED NO EVIDENCE OF RETAINED STONES AND GOOD DRAINAGE. THE POST-OPERATIVE ADDENDUM STATES PATIENT NOTED SOME NAUSEA POST-PROCEDURE, BUT FELT WELL WITHOUT ABDOMINAL PAIN AND WAS DISCHARGED HOME. REVIEW OF THE ERCP XRAY FILMS SHOWED A SUGGESTION OF THE NONCONTAINED AIR AND ILL-DEFINED AREA OF CONTRAST IN THE RIGHT SUBDIAPHRAGMATIC REGION AND RETROPERITONEUM CONCERNING FOR POSSIBLE PERFORATION. FURTHER EVALUATION WITH CT SCAN IS SUGGESTED. THE PATIENT WAS CALLED AND RETURNED TO THE HOSPITAL. A STAT CT OF THE ABDOMEN AND PELVIS WAS PERFORMED WITHOUT CONTRAST AND THE FINDINGS WERE FREE AIR AND RETROPERITONEAL AIR TRACKING INTO THE MEDIASTINUM NOTED WITHOUT DEFINITE FLUID COLLECTION, WHICH COULD BE SEQUELAE OF SMALL BOWEL PERFORATION FROM RETROPERITONEAL HOLLOW VISCUS LIKE AT THE SPHINCTEROTOMY SITE IN THE DUODENUM. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS MADE NPO WITH IV FLUIDS AND IV ANTIBIOTICS. INFECTIOUS DISEASE AND SURGERY WERE CONSULTED. BOTH PHYSICIANS RECOMMENDED OBSERVATION AND TREATMENT WITH ANTIBIOTICS. THE GASTROENTEROLOGIST STATES IN HIS OPERATIVE REPORT ADDENDUM THAT DURING THE SPHINCTEROTOMY USING THE ERBE CAUTERY DEVICE THE MONITOR WENT BLANK SEVERAL TIMES WITH A SHORT AND BIOMED WAS CALLED TO INVESTIGATE THE MACHINE. IT IS UNCLEAR IF THIS CONTRIBUTED TO THE RETROPERITONEAL PERFORATION OR NOT BUT THE VISUALIZATION WAS UNEXPECTEDLY SUBOPTIMAL AT TIMES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
738464 ERBE USA INC. ERBE CAUTERY DEVICE GEI ERBE USA INC. ICC 200
738465 ERBE USA INC ERBE CAUTERY DEVICE GEI ERBE USA INC. APC 300
738466 ERBC USA INC. ERBE CAUTERY DEVICE GEI ERBE USA INC. APC TRAILER

Patients

Seq Age Sex Outcome Treatment
1 79 YR Hospitalization