MAUDE Adverse Event Report: AVALIGN GERMAN SPECIALTY INSTRUMENTS DIVISION BABY JAKES HEMO FORCEPS CVD 4IN(10CM)

Model Number VM25-2385

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reportable device has not been returned for an evaluation by the user facility and is not available for evaluation at this time.A follow up was sent to the facility for return of the device and any additional information.If the reportable device should become available for examination or any additional information from the user facility, a follow up with additional information will be submitted thereafter with results from any additional investigation.

Event Description

Medical specialties ¿ broken ¿ distal end maude report states, "tip of mosquito clamp broke off.It was discovered after the case." additional information received (b)(6) 2016: was the tip accounted for after the procedure? no.Was there any patient injury or intervention? no injury reported.Was there any retained objects? no, tip was not found.The clamp was missing the tip of the clamp on the side.Did the patient require an additional medical procedure such as an x-ray? yes, x-ray completed, found negative for retained object.What type of procedure was being performed? bilateral orchidopexy, right inguinal hernia repair, bilateral ilioinguinal nerve block, meatal calibration meatoplasty.Was the procedure completed as planned? yes.

• Brand Name: BABY JAKES HEMO FORCEPS CVD 4IN(10CM)
• Type of Device: BABY JAKES HEMO FORCEPS
• Manufacturer (Section D): AVALIGN GERMAN SPECIALTY INSTRUMENTS DIVISION; 626 cooper court; schaumburg IL 60173
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6178101
• MDR Text Key: 62861810
• Report Number: 1423507-2016-00078
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/15/2016

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
• Device Operator: No Information
• Device Model Number: VM25-2385
• Device Lot Number: 100312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR