MAUDE Adverse Event Report: STERILMED, INC. SCISSOR TIP MINI ENDOCUT; ELECTROSURGICAL, CUT & COAG ACC, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED

Catalog Number MIC3152

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned for analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent a laparoscopic roux-en-y gastric bypass procedure with a reprocessed scissor tip mini endocut, and a piece of the device dislodged in the abdomen of the patient.The piece was retrieved by the surgeon and the product was replaced.There were no issues noticed prior to the dislodgement and no known circumstance that may have contributed.There was a delay to the procedure.However, the procedure was completed with no patient consequence.Multiple attempts have been made to obtain clarification to this complaint and which part of the device dislodged.However, no further information has been made available.

Manufacturer Narrative

It was reported that a patient underwent a laparoscopic roux-en-y gastric bypass procedure with a reprocessed scissor tip mini endocut, and a piece of the device dislodged in the abdomen of the patient.Additional information was received on the event.The patient was a 51-year-old male, not hispanic/latino.The piece that broke off was just after the shorter tip, it appeared the piece broke in two.This piece is thought to be the protective sheath.The sheath was removed in one piece by the doctor and removed from the sterile field.Imaging was taken at the end of the procedure and showed no retained items seen on x-ray.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a laparoscopic roux-en-y gastric bypass procedure with a reprocessed scissor tip mini endocut, and a piece of the device dislodged during the procedure.The product was returned on 10/23/2019 with the plastic sleeve removed.The device was further visually examined, under magnification, and it is observed that the device appears clean - no visible or obvious indications of use or exposure within the operative field.This is an unusual observation as it was reported that the part broke off inside the patient and was retrieved.Biological contaminants would be expected to be present on any part of the device, as well as the part that broke off, however there was no presence of contaminants of any type.It is observed that the device has been reprocessed twice.Other than the plastic sheath being removed, there were no other observed visual defects.The sheath was further examined and is whole.It is not fractured, sliced or broken.From product specifications, materials: the sleeve behind the distal mechanism is polyethylene resin and the rod coating is polycarbonate.The sheath's only purpose is covering the polycarbonate shell, on which the oem has their logo printed.There is no insulation testing for this type of device.However, it is noted in the inspection and testing procedure, that the inspector will "ensure that the sheath is securely in place by holding the proximal tip and push the sheathing towards the distal tip.Sheathing that is loose or loosens is rejected." this test was conducted on the device.The sheath was reapplied to the device.The sheath remained in position and did not move.A review of the device history record shows that the device passed all visual and functional testing prior to being shipped to the account.A manufacturing record evaluation was conducted and there were no identified nonconformances related to the lot number.The sheath can be twisted and pulled off with some digital manipulation and force, though this was the only determinable way of removing the sleeve from the shaft.Also, per the reprocessed scissor tips instructions for use (ifu), "microline assembly 1.Gently close the blades using your thumb and index finger to ensure blades are completely closed.2.Position tip into shaft with tip blades and hand piece handles in their closed position.3.Turn the rotation knob on the hand piece clockwise until the tip screwed on tight, while holding the blades." as device was removed from its packaging and it is unclear if the technician was using the technique as instructed in the ifu for assembling the scissor tip to the handle, as there would be no reason for contact with the sheath if holding the device by the blades, no conclusion could be determined for why or how the sheath was removed from the shaft of the device.As well, there's no determination why the device or sleeve had no indications of exposure within the operative field.However, during evaluation, the issue could not be duplicated.As the sleeve is not broken or damaged and is not loose, in that it could fall off the shaft.The reported issue is not confirmed.Manufacturer's ref.No: (b)(4).

• Brand Name: SCISSOR TIP MINI ENDOCUT
• Type of Device: ELECTROSURGICAL, CUT & COAG ACC, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 9158994
• MDR Text Key: 178260305
• Report Number: 2134070-2019-00146
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 10888551001816
• UDI-Public: 10888551001816
• Combination Product (y/n): N
• PMA/PMN Number: K073613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2020
• Device Catalogue Number: MIC3152
• Device Lot Number: 2094141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 10/03/2019; 10/23/2019
• Supplement Dates FDA Received: 10/25/2019; 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 51 YR