ATR.INTESTINE.CLIP JAW LENGTH 70MM 3.94N

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL541S - ATR.INTESTINE.CLIP JAW LENGTH 70MM 3.94N. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CLIP IS MISALIGNED. IN LAPARO GASTRIC SURGERY, AN INTESTINAL CLIP WAS GRASPED IN THE DUODENUM AND THE STOMACH WAS INFLATED WITH AIR UNDER AN ENDOSCOPE. AT THAT TIME, THE CLIP FELL OFF. WHEN CHECKED THE CLIP, THE CLIP WAS MISALIGNED AND HAS A GAP OF ABOUT 2 MM. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

INVESTIGATION RESULTS: VISUAL INVESTIGATION: THE CLIP PROVIDED IS IN A USED CONDITION. THE JAWS ARE NOT PARALLEL AND DO NOT CLOSE COMPLETELY. VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. THE CLIP PROVIDED HAS BEEN FORWARDED TO THE RESPONSIBLE Q-COORDINATOR OF THE PRODUCTION PLANT FOR INVESTIGATION. DETAILED INVESTIGATION REPORT ATTACHED TO (B)(4). BASED ON THIS REPORT, THE CLOSING FORCE FOR AS WELL AS THE POSITION OF THE JAWS ARE NO LONGER ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 3(5) X PROBABILITY OF OCCURRENCE 2(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES/PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL, MANUFACTURING OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.