MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO BALL PIVOT ADAPTOR; DORO® BALL PIVOT ADAPTOR

Model Number	3002-50
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer service was contacted on (b)(6) 2020 from customer.Customer stated that a slippage of a ball pivot adapter during procedure occurred.

• Brand Name: DORO BALL PIVOT ADAPTOR
• Common Device Name: DORO® BALL PIVOT ADAPTOR
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 10452782
• Report Number: 3003923584-2020-00019
• Device Sequence Number: 17036384
• Product Code: HBL
• UDI-Device Identifier: 04250435500668
• UDI-Public: 04250435500668
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K001808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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: 3002-50
• Device Catalogue Number: 3002-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/26/2020
• 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: Other