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

Model Number	26183MC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken instrument was not returned for evaluation.
Event or Problem Description
Allegedly, during a laparoscopic supracervical hysterectomy procedure, the loop broke prior to energy being applied and the metal snare came loose in the abdomen and was retrieved with no harm to the patient.They used a second loop to complete the case successfully.

• Brand Name: BRUCKER/MESSROGHLI SPARE LOOP
• 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: 8995235
• Report Number: 9610617-2019-00081
• Device Sequence Number: 3288301
• Product Code: KNF
• UDI-Device Identifier: 04048551393086
• UDI-Public: 4048551393086
• 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
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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: 26183MC
• Device Catalogue Number: 26183MC-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/11/2019
• 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: Required Intervention