MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE BICLAMP LAPAROSCOPIC FORCEPS KELLY; BIPOLAR LAPAROSCOPIC INSTRUMENT

Catalog Number 20195-236

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

It was reported that biclamp laparoscopic instrument was found to be broken during a laparoscopic gynecological operation.The accessory was used with an electrosurgical unit (esu).Specific information regarding the esu, settings, and other devices used were not provided.During the procedure, medical personnel noticed that the fastening screw in the joint area of the biclamp laparoscopic kelly insert was missing.Therefore, an x-ray was performed on the patient, but the screw was not found inside the patient.The screw also was not in the suction bag, on the instrument table, or on the floor.

Manufacturer Narrative

The biclamp laparoscopic instrument was not returned for an evaluation [note: no issues were found upon the review of the lot's device history record (dhr)].However, a photograph was provided showing that the screw was missing from the instrument insert.Based upon similar reports involving this type of accessory, most likely, the instrument became damaged due to wear, mechanical stress (e.G., excessive levering or torsion), etc.However, no conclusive determination can be made at this time.Nevertheless, in the device's notes on use, it is stated that no excessive levering or exerting excessive forces on the instrument must be done, the product must be checked for damage before each use.Damaged/worn out instruments must not be used.Finally, if a root cause to the reported problem is determined upon an inspection of the instrument (if made available), etc.; a follow-up report will be filed.Erbe usa, inc.Is now closing the file on this event.

• Brand Name: ERBE BICLAMP LAPAROSCOPIC FORCEPS KELLY
• Type of Device: BIPOLAR LAPAROSCOPIC INSTRUMENT
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse 17; tubingen, germany 72072 ; GM 72072
• Manufacturer (Section G): ERBE ELEKTROMEDIZIN GMBH; waldhornlestrasse 17; tubingen, germany 72072 ; GM 72072
• Manufacturer Contact: john tartal ; 2225 northwest parkway; marietta, GA 30067-8764 ; 7709554400
• MDR Report Key: 18835864
• MDR Text Key: 336862679
• Report Number: 9610614-2024-00017
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K033421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

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 Catalogue Number: 20195-236
• Device Lot Number: 99581
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2022
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female