MAUDE Adverse Event Report: HNM STAINLESS, LLC DBA HNM MEDICAL HNM SCISSORS; SCISSORS, GENERAL, SURGICAL

Model Number HNM-1-32-750

Device Problem Material Separation (1562)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

This incident was reported to hnm on march 12, 2018.Hnm originally reviewed this complaint and determined that it was not a reportable event due to the fact that there was no patient serious injury or death due to the failure.During a fda audit on april 30 - may 9, 2018, the fda reviewed this complaint and found that the mdr decision tree but does not include adequate evaluation and justification to show that this was not an mdr reportable event and that corrective and preventive action (capa) was not required.Due to this, the complaint was re-evaluated and it has been decided that an mdr is required since this complaint required the surgery to extend thirty extra minutes for the surgeon to locate and remove the broken scissor from the abdominal cavity.

Event Description

Hnm medical scissor (cat # hnm-1-32-750) broke during abdominal surgery.The surgeon was cutting the peritoneum and handed them back to the scrub tech that noticed a piece of the scissors were missing.The patient was already open and no further cuts were made, but the surgeon and tech gently searched the patient and after about 30 min found the missing scissor piece laying on top to the intestines.No clinical complications, just prolonged stay and anesthesia.Patient is currently stable and was not observed to suffer any major complications.

• Brand Name: HNM SCISSORS
• Type of Device: SCISSORS, GENERAL, SURGICAL
• Manufacturer (Section D): HNM STAINLESS, LLC DBA HNM MEDICAL; 20855 ne 16th ave suite c15; miami FL 33179
• Manufacturer (Section G): HNM STAINLESS, LLC DBA HNM MEDICAL; 20855 ne 16th ave suite c15; miami FL 33179
• Manufacturer Contact: dan sragovicz ; 20855 ne 16th ave suite c15; miami, FL 33179 ; 8662918598
• MDR Report Key: 7594106
• MDR Text Key: 111313639
• Report Number: 3005031118-2018-00002
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HNM-1-32-750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization