MAUDE Adverse Event Report: RICHARD WOLF GMBH ENDOSCOPE, NEPHROSCOPE, 25°

Model Number 8972.433

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The medical device shows signs of mechanical damage.The working channel was deformed.The optic was produced in june 2011 and delivered to richard wolf (b)(4) in july 2011.The resolve of the adhesive bond is caused at wear and tear due to numerous treatment cycles.The user is informed about a visual and functional check in chapter 7 in the ifu ("run through the checks before and after each use.").By doing these checks deficiencies or damages can be identified to protect the user from applying this instrument.To our knowledge here is no explainable relationship between the loss of the lens and the removal of the kidney.

Event Description

Richard wolf gmbh was informed in writing from richard wolf (b)(4) about the incident.The distal lens of the 8972,433 fell off during an intervention with ems lithoclast.The lens ended in the kidney of the patient.The kidney was removed completely.

• Brand Name: ENDOSCOPE, NEPHROSCOPE, 25°
• Type of Device: NEPHROSCOPE
• 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: 5333724
• MDR Text Key: 34647847
• Report Number: 9611102-2015-00012
• Device Sequence Number: 1
• Product Code: GCM
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8972.433
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2011
• 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): Hospitalization; Other