MAUDE Adverse Event Report: AESCULAP AG & CO. KG TC DE'BAKEY NEEDLE HOLDERDELSERR165MM

Model Number BM033R

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/08/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).At the end of a hernia surgery, when closing the incision, the needle dropped.After checking, it was found that one tip of the needle holder fractured and the fractured parts were missing.For 2 hours the surgeon and nurse made attempts to locate the missing part using magnet and c-arm x-ray machine; the missing piece was not found.Surgeon had to close incision and end the surgery and was not for sure if the broken part remained in the patient.Patient's hospitalization was prolonged.

Manufacturer Narrative

Manufactring site evaluation: waiting for product return.

• Brand Name: TC DE'BAKEY NEEDLE HOLDERDELSERR165MM
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): AESCULAP AG&CO KG; po box 40; tuttlilngen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert point deive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4269446
• MDR Text Key: 20753442
• Report Number: 2916714-2014-00786
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2014

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: Health Professional
• Device Model Number: BM033R
• Device Catalogue Number: BM033R
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other