MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE BICLAMP LAPAROSCOPIC MARYLAND SMOOTH INSERT; BIPOLAR LAPAROSCOPIC INSTRUMENT

Model Number 20195-147

Device Problem Mechanical Problem (1384)

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

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

The biclamp laparoscopic instrument's insert was disposed of by the medical facility and therefore, it was not returned for an evaluation.There were no issues with the device history record (dhr) of the lot.Based upon other reported events of this type, it appears that mechanical stress (e.G., through levering, bending and frequent reprocessing and progressive wear), was most likely the cause of the device issue.The instrument may have been used even though it was previously damaged.However, no conclusive determination can be made at this time.Nevertheless, in the device's notes on use, it is stated that excessive leverage and excessive (mechanical) forces must not be exerted on the instrument.The product must be checked for damage before each use; defective or damaged products must not be used.The entire instrument must be protected from mechanical damage.Frequent reprocessing and operational stress have an impact on the product.If there is damage or functional impairment, the product may no longer be used.Erbe usa, inc.Is now closing the file on this event.

Event Description

It was reported that a biclamp laparoscopic instrument was found to be missing a screw on its insert while cleaning it after a laparoscopic procedure.The accessory was being used with an electrosurgical unit (esu).Specific information regarding the esu, settings, and other devices used were not provided.It is not clear if the screw came off before the procedure, intraoperatively, or after the procedure while processing.An x-ray examination of the patient showed no metallic foreign bodies in their body.No further information was provided regarding the procedure or the patient.

• Brand Name: ERBE BICLAMP LAPAROSCOPIC MARYLAND SMOOTH INSERT
• 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: 19212109
• MDR Text Key: 341373047
• Report Number: 9610614-2024-00028
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20195-147
• Device Lot Number: 702456
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2022
• 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 Age: 50 YR