MAUDE Adverse Event Report: KARL STORZ SE & CO. KG DILATOR; ENDOSCOPY DILATOR, REUSABLE

Model Number	28185HB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not yet returned to the factory for evaluation.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(4): as reported: "when the dilator was knocked out, the compressed dilating anterior part became detached.No trauma on removal of the loosened dilator part without residue.".
Additional Manufacturer Narrative
Data in section h6 have been corrected to match the evaluation findings.
Additional Manufacturer Narrative
Upon evaluation it could be confirmed that the distal part of instrument was broken.There are many dent and mechanical damaged observed on handle of the device.The breakage area shows no sign of corrosion and it is a freshly break.No indication for a material or manufacturing related issue was found during the investigation.In conclusion, the root cause most likely is due to mechanical overload, such as exerting too much force.This is user error without patient harm, therefore the case is non reportable.

• Brand Name: DILATOR
• Common Device Name: ENDOSCOPY DILATOR, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 11171204
• Report Number: 9610617-2021-00014
• Device Sequence Number: 3726454
• Product Code: LXH
• UDI-Device Identifier: 04048551310328
• UDI-Public: 4048551310328
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2022

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: 28185HB
• Device Catalogue Number: 28185HB
• Device Lot Number: VR02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 12/01/2021; 08/10/2022
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 08/09/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown