MAUDE Adverse Event Report: RICHARD WOLF GERMANY (RWGMBH) CANNULA FOR INJECTION

Model Number 8383.60

Device Problems Break (1069); Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2017

Event Type  Injury  

Event Description

Richard wolf medical instrument corporation (rwmic) was notified by fda.Voluntary event report #: mw5071751.During a procedure the laparoscopic 22 gauge needle broke (device i.D.(b)(4)).The surgeon attempted to find needle fragment but he couldn't.X-ray showed that needle fragment had migrated into the abdomen, under the diaphragm.Patient returned to operating room for successfully removal of needle fragment.No injury to the patient was reported.No similar events resulting in an mdr have occurred on this device in the last three years.User facility contacted in an effort to gather additional / missing information, via email (twice), no response as of 10/02/2017.As of today, 02 of october, 2017, device has not been returned to rwmic.Rwmic considers this matter closed.However, in the event rwmic receives additional information, a follow-up report will be provided to the manufacturer of the device.

Manufacturer Narrative

Richard wolf medical instruments corporation (rwmic) received an email from user facility on 13oct2017 with additional information.New information added to this follow up report.Rmic considers this matter closed.However, in the event rwmic receives any additional information a follow report will be submitted to fda.

Event Description

Follow up report #1.Procedure performed - laparoscopic intrafascial hysterectomy with left salpingo-oophorectmy.

• Brand Name: CANNULA FOR INJECTION
• Type of Device: CANNULA
• Manufacturer (Section D): RICHARD WOLF GERMANY (RWGMBH); 32 pforzheimer street; knittlingen, 75438 ; GM 75438
• MDR Report Key: 6907494
• MDR Text Key: 87998573
• Report Number: 1418479-2017-00022
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/07/2017,09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8383.60
• Device Catalogue Number: 8383.60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2017
• Distributor Facility Aware Date: 09/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 84