MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CANNULA WITH LUER LOCK; CANNULA WITH LUER LOCK FOR USE WITH TROCAR

Model Number	30114G2
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cannula and lap scissors are being kept at the faculty, therefore no evaluation can be done.
Event or Problem Description
Allegedly, per the customer, during a laparoscopic ventral hernia repair, the tip of the metal cannula was bent which shaved off insulation from the lap scissor.The surgeon had to excise burned skin leaving a slightly larger scar, no fragments were left in the patient and a post op follow up indicated the burn was healing with no other intervention required.

• Brand Name: CANNULA WITH LUER LOCK
• Common Device Name: CANNULA WITH LUER LOCK FOR USE WITH TROCAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9356670
• Report Number: 9610617-2019-00110
• Device Sequence Number: 19372684
• Product Code: GCJ
• UDI-Device Identifier: 04048551254769
• UDI-Public: 4048551254769
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K940347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2019

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: 30114G2
• Device Catalogue Number: 30114G2
• Device Lot Number: YT02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2019
• 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: 57 YR
• Patient Weight: 68