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

Model Number	26183MD-S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken instrument was returned for evaluation.We confirmed that the electrode is broken but still intact.The loop itself is a single use item and most likely it arced during use and broke off.
Event or Problem Description
Allegedly, during a laparoscopic supracervical hysterectomy procedure, the supraloop broke and the colon was nicked.Per the nurse manager, "the patient was harmed but the wound was repaired in surgery, no further complications noted".

• 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: 8794079
• Report Number: 9610617-2019-00059
• Device Sequence Number: 11519959
• Product Code: OHD
• 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
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

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: 26183MD-S
• Device Catalogue Number: 26183MD-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/16/2019
• 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
• Patient Age: 25 YR
• Patient Weight: 68