MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OUTER TUBE GRASPING INSERT; OUTER TUBE WITH INSERT FORCEPS GRASPER

Model Number	30310ONS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned, therefore; the product could not be evaluated.The date code of 2006 indicates the product is 14 years old, possible stress of over usage.
Event or Problem Description
Allegedly, per the operating room manager, during a laparoscopic hernia procedure a large piece of plastic "sheared off " and fell into the patient.The doctor successfully retrieved the piece with no harm to the patient; procedure was completed with no additional intervention.

• Brand Name: OUTER TUBE GRASPING INSERT
• Common Device Name: OUTER TUBE WITH INSERT FORCEPS GRASPER
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 10338711
• Report Number: 9610617-2020-00087
• Device Sequence Number: 14219399
• Product Code: GCJ
• UDI-Device Identifier: 04048551121887
• UDI-Public: 4048551121887
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K935071
• 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): 07/28/2020

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: 30310ONS
• Device Catalogue Number: 30310ONS
• Device Lot Number: KD
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/29/2020
• 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