MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROBI FORCEPS INSERT; ROBI FORCEPS CLERMONT-FERRAND INSERT

Model Number	38610ON
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per evaluation findings the complete instrument head was separated from distal end of shaft.
Event or Problem Description
Allegedly, during a laparoscopic procedure, when the doctor noticed the instrument did not work and found the entire distal tip of the forceps fell into the patient.The loose piece was retrieved and the procedure was completed with another instrument.

• Brand Name: ROBI FORCEPS INSERT
• Common Device Name: ROBI FORCEPS CLERMONT-FERRAND INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9010083
• Report Number: 9610617-2019-00080
• Device Sequence Number: 2529480
• Product Code: GEI
• UDI-Device Identifier: 04048551328651
• UDI-Public: 4048551328651
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K962030
• 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): 09/10/2019

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: 38610ON
• Device Catalogue Number: 38610ON
• Device Lot Number: PQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/12/2019
• 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: 50 YR