MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BRUCKER/MESSROGHLI SUPRALOOP; SPARE SUPRA LOOP STERILE PACKAGE OF 6

Model Number 26183MC-S

Device Problems Break (1069); Material Separation (1562)

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

Event Date 05/03/2022

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned, therefore no evaluation has been completed.

Event Description

During a laparoscopic supra cervical hysterectomy, the loop broke.The surgeon completed the case with another loop, with no impact to the patient.

• Brand Name: BRUCKER/MESSROGHLI SUPRALOOP
• Type of Device: SPARE SUPRA LOOP STERILE PACKAGE OF 6
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 14495485
• MDR Text Key: 292595216
• Report Number: 9610617-2022-00077
• Device Sequence Number: 1
• Product Code: KNF
• UDI-Device Identifier: 04048551393086
• UDI-Public: 4048551393086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26183MC-S
• Device Catalogue Number: 26183MC-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female