MAUDE Adverse Event Report: HEBUMEDICAL GMBH BABY BABCOCK INTESTINAL FCPS 5-1/2; INTESTINAL FORCEPS

Catalog Number 16-42

Device Problem Off-Label Use (1494)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

No complaint or actual event could be confirmed and no device was available for evaluation.Manufacturing records were reviewed and no nonconformances found.Due to the wording of the initial report received by the distributor, it seems that the device may have been used inappropriately, since special atraumatic babcock forceps are available to prevent trauma in sensitive tissue.

Event Description

As per mfr (importer) report# (b)(4): dealer initially reported defectuous handle.(b)(6) 2014 dealer reported babcock forceps have sharp tips and generate trauma in abdominal tissues, allegedly producing adverse events in patients.Dealer has not confirmed that an event actually occurred.On 4/25/2014 after five more requests, no further response from dealer.

• Brand Name: BABY BABCOCK INTESTINAL FCPS 5-1/2
• Type of Device: INTESTINAL FORCEPS
• Manufacturer (Section D): HEBUMEDICAL GMBH; badstrasse 8; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): HEBUMEDICAL GMBH; badstrasse 8; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: thomas butsch ; badstrasse 8; tuttlingen, 78532 ; GM 78532 ; 46194710
• MDR Report Key: 5671944
• MDR Text Key: 46723827
• Report Number: 3002806609-2016-00004
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-42
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1