MAUDE Adverse Event Report: KARL STORZ SE & CO. KG NEEDLE,VERESS,PNEUMOPERITONEUM; NEEDLE, VERESS

Model Number	26120J
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the factory in germany, according to first risk assessment done by safety officer, there are no indications for a systemic problem.Product has not been returned for evaluation.
Event or Problem Description
Per the factory in (b)(6), allegedly, the tip of the veress needle broke off in the patient.No impact to patient or user described.

• Brand Name: NEEDLE,VERESS,PNEUMOPERITONEUM
• Common Device Name: NEEDLE, VERESS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9990276
• Report Number: 9610617-2020-00051
• Device Sequence Number: 13647466
• Product Code: GCJ
• UDI-Device Identifier: 04048551093917
• UDI-Public: 4048551093917
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K951251
• 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): 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 26120J
• Device Catalogue Number: 26120J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 04/23/2020
• 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