MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® QR3 SKULL CLAMP; DORO® QR3 SKULL CLAMP TEFLON

Model Number 3003-009

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

No corrective action necessary, no failure on the device found.

Event Description

Customer support was contacted on 08/15/2017 regarding a possible slippage.The sales representative called in and reported that the incident possibly happened at the hospital last thursday (b)(6) 2017.He could not confirm date when speaking to or manager.He said he was not on shift when it happened.I was able to get serial #'s from the representative that called in but could not confirm they were correct when speaking to him.Returned goods form received from hospital on 08/21/2017: - risk for patient: yes, - description of risk: lock slipping, possible injury, - surgery completed: yes with another skull clamp.

• Brand Name: DORO® QR3 SKULL CLAMP
• Type of Device: DORO® QR3 SKULL CLAMP TEFLON
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: sandra untenberger ; boetzinger str. 38; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 6844396
• MDR Text Key: 84948847
• Report Number: 3003923584-2017-00036
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435500781
• UDI-Public: (01)04250435500781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2017

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
• Device Operator: No Information
• Device Model Number: 3003-009
• Device Catalogue Number: 3003-009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention