MAUDE Adverse Event Report: MICROLINE SURGICAL, INC RENEW ENDOCUT SCISSOR TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 3152

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/18/2022

Event Type  Injury  

Event Description

I was reported that a loriegn body was removed from a patient during surgery.Item is a plastic sheath with ¿microline¿ ¿single use only¿.On (b)(6) 2022, it was reported by another facility to this patient safely officer that a foreign body was removed from a patient during surgery.The foreign body was described a piece of black plastic with the words printed on it; ¿microline¿ ¿single use only¿.Review of the patient¿s prior medical history revealed that she had a operating room laparoscopic cholecystectomy performed on (b)(6) 2022 at delray medical center.Description of procedure: the patient was brought to the operating room and placed in a supine position.After adequate endotracheal anesthesia, an og was placed in the stomach.The abdomen was prepped and draped in the normal fashion.A 1 cm incision above the belly button was performed and a veress needle was placed into the abdominal cavity.The abdominal cavity was insufflated with co2 gas to a pressure of 50 mmhg.The 5 mm port was placed under vision using avisiport.A camera was placed through the port and exploration revealed the above findings.An additional 3 ports were placed in the normal laparoscopic cholecystectomy position.The gallbladder was retracted, and a needle suction was used to suck the gallbladder content.Dissection of the cystic artery was performed.Continue relevant history below.Three clips were placed on the cystic duct proximally and one clip dietally and this was transected with scissors.The gall bladder was dissected from the liver bed using traction and abovie caulery.Good hemostasis was noted.The gallbladder was removed using an endocatch.Three ports were removed, and the wounds were irrigated with normal saline.A supraumbilical incision was ckosed with 2 layer, 0 vicryl figure-of-eight stitch to approximate the fascia and 4-o vicryl subcuticular layer to approximate the skin.Additional three port sites were closed with a 4-0 vicryl subcuticular layer.Polysporin was applied and the wound was covered with a sterile dressing.The patient tolerated the procedure very well with no complications.

• Brand Name: RENEW ENDOCUT SCISSOR TIP
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MICROLINE SURGICAL, INC; 50 dunham rd; beverly, MA 01915
• MDR Report Key: 16086081
• MDR Text Key: 306681944
• Report Number: MW5114126
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3152
• Device Catalogue Number: 3142RH
• Device Lot Number: 00163941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White