MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FORCEPS, OPTICAL, F/PEDIATRIC BRONCHO-; PED OPTICAL PEANUT FORCEPS

Model Number	10378KF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not yet been returned for evaluation, and we have so far been unable to obtain further details of this event.
Event or Problem Description
Allegedly, item broke during a procedure; no patient injury reported.
Event or Problem Description
One of the forceps jaws broke off during a rigid esophagoscopy with coin removal from proximal esophagus procedure.The broken jaw was noted to be laying in posterior oropharynx and was retrieved.New forceps were then used to retrieve coin.The doctor confirmed there was no harm to patient.
Additional Manufacturer Narrative
Per the evaluation findings: the shaft is severely bent and the jaws are broken.Breakage was most likely due to normal wear and tear.Device was in use for over 16 years.

• Brand Name: FORCEPS, OPTICAL, F/PEDIATRIC BRONCHO-
• Common Device Name: PED OPTICAL PEANUT FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 11174991
• Report Number: 9610617-2021-00011
• Device Sequence Number: 2231681
• Product Code: EOQ
• UDI-Device Identifier: 04048551047620
• UDI-Public: 4048551047620
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K943700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: 10378KF
• Device Catalogue Number: 10378KF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 03/12/2021
• 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: Other
• Patient Age: 2 YR