MAUDE Adverse Event Report: CONMED CORPORATION POOLE WITH REMOVABLE SHEATH; SUCTION INSTRUMENT

Catalog Number	0035040
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conmed corporation received two (2) "unopened" packages containing the poole with removable sheath for evaluation.The two packages were transferred to the packaging engineering lab for evaluation on 21-apr-2017.Visual examination of the returned packages found both packages open with product in the seal area of the complaint.Due to damage seen on the products, there is evidence that the devices were sealed within the sterile seal of the package.This complaint was confirmed regarding "the seal of the sterile pouch was breached." this lot was manufactured on 03-oct-2017.A review of the manufacturing documents from the dhr/lhr has verified the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.Of the lot containing (b)(4), there are no similar complaints received.A two (2) year review of product history for this devices included in the capa investigation showed a total of (b)(4) complaints, involving (b)(4) devices, including this complaint, regarding insufficient heat seals.During this same two (2) year time frame, over (b)(4) units were sold worldwide, making the occurrence rate for this reported failure mode (b)(4) percent.The reported packaging anomaly was obvious to the distributor and therefore prompted the return of the device for evaluation and replacement.This failure mode is addressed in the risk documents.To date, there have been no serious injuries or death related to this reported problem.Nonetheless, to prevent future recurrences, an investigation is in progress to determine the root cause and to address this reported problem.As with all medical devices, examination of packaging occurs multiple times prior to use (shipping/receiving, distribution, storage and prior to use).In addition, good clinical practice would include examination and verification of the product and its original packaging to ensure both are intact.If the product and its packaging have been opened/damaged or altered, do not use the product and contact the manufacturer immediately.
Event or Problem Description
The distributor in (b)(6) reported that during receiving and inspection of incoming products, two (2) packages, containing one each poole with removable sheath, were discovered with "the seal of the sterile pouch was breached." in this instance, there was no patient involvement with this reported problem, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to an end-user.This report is being filed based on the potential for injury with recurrence.

• Brand Name: POOLE WITH REMOVABLE SHEATH
• Common Device Name: SUCTION INSTRUMENT
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6523353
• Report Number: 1320894-2017-00102
• Device Sequence Number: 495347
• Product Code: BYY
• UDI-Device Identifier: 10653405000389
• UDI-Public: (01)10653405000389(17)211002(10)201610031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K780724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2017

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
• Operator of Device: No Information
• Device Expiration Date: 10/02/2021
• Device Catalogue Number: 0035040
• Device Lot Number: 201610031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1