FDA Adverse Event Malfunction Summary report: N

10MM, 33CM RATCHETING HANDLE

MDR report key: 4252357 · Received November 14, 2014

Report

Report Number: 0002936485-2014-00931
Event Type: Malfunction
Date Received: November 14, 2014
Date of Event: October 23, 2014
Report Date: October 23, 2014
Manufacturer: STRYKER ENDOSCOPY-SAN JOSE
Product Code: KOG
PMA / PMN Number: K973259
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. DENTS AND SCRATCHES WERE SEEN ON THE INSULATION DURING VISUAL INSPECTION. THE PROBABLE ROOT CAUSES COULD BE NORMAL WEAR AND TEAR AND OR MISHANDLING. IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

Additional Manufacturer Narrative · 1

THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. DENTS AND SCRATCHES WERE SEEN ON THE INSULATION DURING VISUAL INSPECTION. IFU 10000401070 "BEFORE USE, ENSURE THAT THERE ARE NO BREAKS, CHIPS, CRACKS, SCRATCHES, TEARS, OR MISSING/LOOSE COMPONENTS ON THE SHAFT INSULATION, HANDLE, OR HOUSING. DO NOT USE THE INSTRUMENT IF ANY OF THESE DEFECTS ARE PRESENT AS THIS COULD CAUSE UNINTENDED ELECTROSURGICAL BURNS AND LIFE-THREATENING COMPLICATIONS. IF DAMAGE HAS OCCURRED, DISCONTINUE USE AND RETURN THE INSTRUMENT FOR REPAIR OR REPLACEMENT." THE PROBABLE ROOT CAUSES COULD BE NORMAL WEAR AND TEAR AND OR MISHANDLING. IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE INSULATION HAS BEEN COMPROMISED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE INSULATION HAS BEEN COMPROMISED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
736138	10MM, 33CM RATCHETING HANDLE	ENDOSCOPE AND/OR ACCESSORIES	KOG	STRYKER ENDOSCOPY-SAN JOSE		1045186D

Patients

Seq	Age	Sex	Outcome	Treatment
1