MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BRUCKER/MESSROGHLI SUPRALOOP LARGE; GYNECOLOGY SUPRA LOOP

Model Number	26183MD-S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has not been returned, therefore no evaluation could be completed.
Event or Problem Description
Allegedly, during a laparoscopic supracervical hysterectomy procedure, the supraloop broke during removal of uterus and caused bleeding.Per the nurse the bleeding vessel was clipped to obtain hemostasis in surgery, no further treatment required.

• Brand Name: BRUCKER/MESSROGHLI SUPRALOOP LARGE
• Common Device Name: GYNECOLOGY SUPRA LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• MDR Report Key: 11738350
• Report Number: 9610617-2021-00042
• Device Sequence Number: 11703982
• Product Code: KNF
• UDI-Device Identifier: 04048551393567
• UDI-Public: 4048551393567
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944793
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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
• Operator of Device: Health Professional
• Device Model Number: 26183MD-S
• Device Catalogue Number: 26183MD-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Weight: 117