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

Model Number 26183MD-S

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  malfunction  

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 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
• Type of Device: GYNECOLOGY SUPRA LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm,
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188201
• MDR Report Key: 8794079
• MDR Text Key: 151327388
• Report Number: 9610617-2019-00059
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 04048551393567
• UDI-Public: 4048551393567
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 68