MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PROCINCH ADJUSTABLE LOOP IMPLANT, REVERSE TENSIONING; PIN, FIXATION, SMOOTH

Catalog Number 0234102060

Device Problem Device Expiration Issue (1216)

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

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

Alleged failure: expired product was used.Probable root cause: design: validated shelf life too short; shelf life/expiration date not adequately published on package.Application: distribution inefficient, sat too long in inventory before being shipped to customer; user inattentive to expiration date of product.The product was not returned for investigation, therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported that an expired implant was used in a patient.There were no reports of adverse consequences.

• Brand Name: PROCINCH ADJUSTABLE LOOP IMPLANT, REVERSE TENSIONING
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: ashley lower ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7114243
• MDR Text Key: 95486660
• Report Number: 0002936485-2017-01201
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017

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 Catalogue Number: 0234102060
• Device Lot Number: 15302AE2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1