MAUDE Adverse Event Report: RICHARD WOLF GMBH RIGID ENDOSCOPE SHEATH; WORKING ELEMENT

Model Number 8680.224

Device Problem Break (1069)

Patient Problems Blood Loss (2597); Foreign Body In Patient (2687)

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

Richard wolf (b)(4) has not received actual device or photos of device as of 03/25/2016.There have been no similar incidents reported on this product.(b)(4) considers this report closed.If (b)(4) receives any new information a follow up report will be sent to fda.(b)(4).Not returned.

Event Description

During surgery, the handpiece suddenly divided into two parts, the operation could not proceed normally, so the operation has to be stopped while the doctor took out the broken part from the body of the patient.Because the surgical instrument was damaged during operation, the hospital had to use an alternate system to continue and complete the procedure.As surgery prolonged, patient had excessive bleeding, patients had been given 400ml blood transfusion.

• Brand Name: RIGID ENDOSCOPE SHEATH
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: oliver ehrlich ; 32 pforzheimer street; knittlingen, 75438 ; GM 75438 ; 043351013
• MDR Report Key: 5522606
• MDR Text Key: 41047303
• Report Number: 9611102-2016-00014
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 8680.224
• Device Lot Number: 1260601
• Initial Date Manufacturer Received: 02/26/2016
• Initial Date FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2014
• 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
• Patient Age: 77 YR
• Patient Weight: 70