MAUDE Adverse Event Report: ELMED INCORPORATED V MUELLER / ELMED L-HOOK CAUTERY TIP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number F265.00

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

Product is not available for review/investigation v mueller provided us with a copy of the customer's submission; noting the sample, lot number and pictures are not available.They asked for pictures of this particular item so that they could write up a complaint from their end.Elmed inc asked v mueller to reconfirm that the actual product was not available and could not be sent back to us.They confirmed stating that the customer did not have it.Last time our distributer (v.Mueller) ordered this particular item was at least 6 years ago.No other complaints have been received on this product as per the customer's report, there was no harm to the patient.

Event Description

During a laparoscopic cholecystectony, the surgeon was using the cautery device.When he removed the "l-hook," the scrub nurse noticed that the v-mueller l hook cautery tip was no longer in place on the shaft of the device.An abdominal x-ray was taken after the procedure showing no retained foreign object.The instrument was taken out of service.No harm to patient.

• Brand Name: V MUELLER / ELMED L-HOOK CAUTERY TIP
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ELMED INCORPORATED; 35 n brandon dr; glendale heights IL 60139
• Manufacturer (Section G): ELMED INCORPORATED; 35 n brandon dr; glendale heights 60139
• Manufacturer Contact: sabine hausner ; 35 n brandon dr; glendale heights, IL 60139 ; 2243536446
• MDR Report Key: 18187414
• MDR Text Key: 328972962
• Report Number: 1412854-2023-07010
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/21/2023

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 Model Number: F265.00
• Device Catalogue Number: F265.00
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Race: White