COLONIC FTRD SET
Received Jun 1, 2022 · Event occurred Dec 28, 2021
Report 3006696607-2022-00002 · MDR key 14559016
Device
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
Unknown
- Bowel Perforation
- Bowel Perforation
Narrative
Description of Event or Problem
A COLONIC FTRD SET (CFTRD), MANUFACTURER OVESCO ENDOSCOPY (B)(4), WAS USED FOR AN ENDOSCOPIC FULL THICKNESS RESECTION OF A 2 CM SIZE LESION IN THE TRANSVERSE COLON. THE ENDOSCOPIC INTERVENTIONIST ASSUMED THAT THE CLIP OF THE COLONIC FTRD SET IN QUESTION HAD BEEN SUCCESSFULLY APPLIED AND, HENCE, PROCEEDED TO PERFORM THE FULL THICKNESS RESECTION. HOWEVER, CLIP APPLICATION WAS VISUALLY NOT VERIFIED BEFOREHAND. AFTER RESECTION OF THE LESION, THE PERFORATION WAS QUICKLY RECOGNIZED. THE PHYSICIAN TRIED TO CLOSE THE PERFORATION BY USING OTSC CLIPS AND OTHER INSTRUMENTS WITHOUT COMPLETE SUCCESS. THEREFORE ABDOMINAL COLONIC SURGERY BECAME NECESSARY. THE PATIENT RECOVERED UNEVENTFULLY.
Additional Manufacturer Narrative
IN SUMMARY, THERE IS NO INDICATION OF A TECHNICAL FAILURE OF THE DEVICE. NONE OF THE DMRS SHOWED ANY DEVIATION. THE RISK OF CAUSING A PERFORATION IS INDICATED IN THE INSTRUCTION FOR USE. MOREOVER, IT IS ADDRESSED IN USER TRAININGS WE PERFORM. IT IS RECOMMENDED TO VERIFY A SUCCESSFUL CLIP APPLICATION BEFORE RESECTING THE TARGET TISSUE. IN CONCLUSION, THE DETERMINED ROOT CAUSE IS A PROCEDURAL COMPLICATION, NOT A TECHNICAL FAILURE.