MAUDE Adverse Event Report: KARL-STORZ ENDOSCOPY-AMERICA, INC. BRUCKER/MESSROGHLI EXTRA LARGE SUPRALOOP SPARE LOOP; COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)

Model Number REF# 26183MD-S

Device Problem Break (1069)

Patient Problems Laceration(s) (1946); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/03/2021

Event Type  Injury  

Event Description

While performing a laparoscopic supracervical hysterectomy, the product was placed around the uterus to separate the uterine fundus from the cervix.Upon activation of the cautery, the loop broke and one end of the broken loop nicked the patient's adjacent blood vessel causing bleeding.The vessel was subsequently clamped and clipped to maintain hemostasis.

• Brand Name: BRUCKER/MESSROGHLI EXTRA LARGE SUPRALOOP SPARE LOOP
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, UNIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): KARL-STORZ ENDOSCOPY-AMERICA, INC.
• MDR Report Key: 11422157
• MDR Text Key: 238624006
• Report Number: MW5099815
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): Y
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: REF# 26183MD-S
• Device Lot Number: 37LI1734
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 109