FDA Adverse Event Injury Summary report: N

CARB-BITE MAYO-HEGAR NEEDLE HOLDER 6

MDR report key: 9098171 · Received September 20, 2019

Report

Report Number: 8010168-2019-00002
Event Type: Injury
Date Received: September 20, 2019
Report Date: September 20, 2019
Manufacturer: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG
Product Code: FHQ
UDI-DI: 10381780377160
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE NEEDLE HOLDERS MENTIONED IN THE FACILITY NARRATIVE HAVE NOT BEEN RETURNED FOR INSPECTION. IT HAS THEREFORE NOT BEEN POSSIBLE TO CONFIRM THE ALLEGED FAILURES (BROKEN TIP, SUTURE NOT HELD) NOR THE IDENTITY OF THE FOREIGN BODY DETECTED ON THE X-RAY. THE LOT NUMBER IS NOT AVAILABLE AND MANUFACTURING HISTORY CANNOT BE REVIEWED. REPEATED ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE HEALTHCARE FACILITY. IF ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

WHILE USING THE 121135 CARB-BITE MAYO-HEGAR NEEDLE HOLDER 6 ON A PATIENT DURING AN UNSPECIFIED PROCEDURE, THE DEVICE FAILED TO HOLD SUTURE. THE SURGEON TRIED USING A SECOND 121135 CARB-BITE MAYO-HEGAR NEEDLE HOLDER 6, BUT IT ALSO FAILED TO HOLD SUTURE. POSTOPERATIVELY, AFTER THE CLOSURE OF THE PATIENT, AN X-RAY WAS TAKEN. A FOREIGN BODY WAS SEEN ON THE FILM. THE SCRUB TECHNICIAN WENT BACK TO THE TRAY AND NOTICED THAT THE DEVICE HAD A BROKEN TIP. THE PATIENT WAS LATER BROUGHT BACK INTO SURGERY AND HAD THE NEEDLE HOLDER TIP REMOVED. THERE WAS AN UNSPECIFIED INJURY AND DELAY IN SURGERY REPORTED. (EVENT REPORT FOR DEVICE #2 OF 2)

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
891065	CARB-BITE MAYO-HEGAR NEEDLE HOLDER 6	NEEDLE HOLDER	FHQ	GEOMED MEDIZIN-TECHNIK GMBH & CO. KG			10381780377160

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention